Events

Rappel de Device Recall Philip's HeartStart FR3 Automated External Defibrillator (AED)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems North America Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67622
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1225-2014
  • Date de mise en oeuvre de l'événement
    2014-02-06
  • Date de publication de l'événement
    2014-03-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125857
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    Philip's is recalling heartstart fr3 automated external defibrillator (aed) because the printed circuit board (pcb), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. in the event the pcb becomes separated from the electrical contact points, the aed may not be ready to deliver a shock in the event of an emergency.
  • Action
    Philips sent an Urgent Medical Device Recall Letter dated February 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you are have an affected device, please contact Philips for a replacement AED at 1-800-263-3342 and select option 5. Live technical support is available Monday through Friday, 7:00AM to 5:00PM PST. You can also leave a message 24 hours a day, seven days a week; a customer support representative will return your call promptly on the next business day. Customers who have an affected device will be supplied with a replacement AED device of the same model as the recalled device from Philips, free of charge. Please keep your AED in service until you receive a replacement if there are no alternative defibrillators readily available. Philips has asked Distributors to provide them with the following information within five calendar days: -The name, address, telephone number and, if available, email address of all customers who received affected devices from you or from any of your sub-distributors. -The serial numbers of any affected devices remaining in their possession, or in the possession of their sub-distributors. -Philips directed distributors with affected devices in inventory to not sell these products, but to note them as in their possession as part of their response to Philips. -Philips communicated in this letter that they are responsible for returning to Philips any units in their inventory or in the inventory of their sub-distributors, and Philips will provide instructions for returning the affected devices.

Device

Device Recall Philip's HeartStart FR3 Automated External Defibrillator (AED)
  • Modèle / numéro de série
    Serial numbers of units distributed in the USA: C13A-00592, C13C-00131, C13C-00150, C13C-00270, C13C-00679, C13C-00681, C13C-00769, C13D-00048, C13D-00197, C13E-00088, C13E-00168, C13E-00234, C13E-00242, C13E-00245, C13E-00326, C13E-00340, C13E-00368, C13E-00372, C13E-00380, C13E-00382, C13E-00390, C13E-00406, C13E-00495, C13E-00507, C13E-00511, C13E-00516, C13E-00526, C13E-00537, C13F-00011, C13F-00012, C13F-00013, C13F-00022, C13F-00024, C13F-00027, C13F-00031, C13F-00032, C13F-00033, C13F-00035, C13F-00038, C13F-00043, C13F-00047, C13F-00053, C13F-00054, C13F-00059, C13F-00071, C13F-00077, C13F-00078, C13F-00102, C13F-00104, C13F-00110, C13F-00114, C13F-00118, C13F-00126, C13F-00131, C13F-00137, C13F-00138, C13F-00140, C13F-00143, C13F-00146, C13F-00148, C13F-00168, C13F-00172, C13F-00173, C13F-00174, C13F-00180, C13F-00181, C13F-00198, C13F-00202, C13F-00212, C13F-00214, C13F-00215, C13F-00217, C13F-00218, C13F-00224, C13F-00225, C13F-00227, C13F-00232, C13F-00233, C13F-00236, C13F-00238, C13F-00239, C13F-00240, C13F-00244, C13F-00246, C13F-00250, C13F-00255, C13F-00266, C13F-00273, C13F-00274, C13F-00275, C13F-00278, C13F-00284, C13F-00291, C13F-00294, C13F-00307, C13F-00309, C13F-00318, C13F-00321, C13F-00322, C13F-00323, C13F-00329, C13F-00330, C13F-00331, C13F-00332, C13F-00336, C13F-00348, C13F-00353, C13F-00468, C13F-00543, C13F-00559, C13F-00567, C13F-00578, C13F-00590, C13F-00593, C13F-00595, C13F-00599, C13F-00604, C13F-00607, C13F-00651, C13F-00778, C13G-00008, C13G-00010, C13G-00035, C13G-00056, C13G-00057, C13G-00282, C13G-00284, and C13H-00062.  Serial numbers of units outside the USA:  C13C-00004, C13C-00256, C13C-00305, C13C-00323, C13C-00608, C13C-00639, C13E-00009, C13E-00021, C13E-00036, C13E-00048, C13E-00057, C13E-00058, C13E-00065, C13E-00163, C13E-00250, C13E-00265, C13E-00273, C13E-00311, C13E-00323, C13E-00328, C13E-00339, C13E-00341, C13E-00345, C13E-00346, C13E-00349, C13E-00350, C13E-00351, C13E-00358, C13E-00393, C13E-00395, C13E-00404, C13E-00407, C13E-00409, C13E-00424, C13E-00437, C13E-00441, C13E-00452, C13E-00454, C13E-00455, C13E-00499, C13E-00503, C13E-00518, C13E-00527, C13E-00535, C13E-00548, C13F-00010, C13F-00280, C13F-00286, C13F-00293, C13F-00298, C13F-00302, C13F-00303, C13F-00305, C13F-00306, C13F-00316, C13F-00317, C13F-00343, C13F-00345, C13F-00346, C13F-00358, C13F-00363, C13F-00369, C13F-00371, C13F-00381, C13F-00385, C13F-00391, C13F-00400, C13F-00420, C13F-00424, C13F-00428, C13F-00436, C13F-00473, C13F-00498, C13F-00539, C13F-00565, C13F-00579, C13F-00580, C13F-00583, C13F-00586, C13F-00587, C13F-00606, C13F-00619, C13F-00627, C13F-00629, C13F-00649, C13F-00666, C13F-00668, C13F-00677, C13F-00678, C13F-00682, C13F-00685, C13F-00687, C13F-00726, C13F-00742, C13F-00746, C13F-00748, C13F-00755, C13F-00758, C13F-00760, C13F-00782, C13F-00797, C13F-00815, C13F-00870, C13F-00889, C13F-00896, C13F-00938, C13G-00026, C13G-00039, C13G-00084, C13G-00126, C13G-00132, C13G-00142, C13G-00237, C13G-00247, C13G-00293, C13G-00315, C13G-00331, C13G-00337, C13G-00345, C13G-00407, C13G-00435, C13G-00451, and C13H-00035.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of AL, CA, CO, WA DC, FL, GA, HI, KS, MD, ME, MI, MS, NC, NM, NY, PA, TX, VA, WA and WI., and the countries of Australia, Austria, Canada, France, Germany, India, Italy, Ireland, Japan, Malaysia, Netherlands, Norway, Switzerland, Taiwan and United Kingdom.
  • Description du dispositif
    Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. || The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: -Unresponsiveness -Absence of normal breathing If in doubt, apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment.
  • Manufacturer
    Philips Medical Systems North America Inc.

Manufacturer

Philips Medical Systems North America Inc.
  • Adresse du fabricant
    Philips Medical Systems North America Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA