Events

Rappel de Device Recall Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs)

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
    67612
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1232-2014
  • 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
    2017-03-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125837
  • 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
    Philips is recalling heartstart home and onsite (hs1) automated external defibrillators (aeds) because one or both contact pins may be contaminated by residue from the soldering process. this contamination could prevent an adequate connection between the pads cartridge and the aed. if poor contact between the pads cartridge and aed occurs, the device may be unable to deliver therapy in an emergency.
  • Action
    Philips began sending out the Urgent Medical Device Recall HeartStart Home and OnSite (HS1) letter, dated 2014 FEB 10, to consignees on 2/17/14. The letter identified the product, the problem, and the action to be taken by the customer. Customers are advised to 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. Customers can also leave a message 24 hours a day, seven days a week. DISTRIBUTORS are instructed to provide Philips with the information provided in the letter. Customers who have an affected device will be supplied with a replacement AED from Philips, free of charge. If customers/distributors need any further information or support concerning this issue, please visit www.philips.com/HeartStartHS1PinAction.

Device

Device Recall Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs)
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Description du dispositif
    Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). || Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. || Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).
  • 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