Events

Rappel de HeartSine Samaritan(R) 300/300P PAD devices

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 Heartsine Technologies, Limited.

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
    63139
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0124-2013
  • Date de mise en oeuvre de l'événement
    2012-09-13
  • Date de publication de l'événement
    2012-10-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112662
  • 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 - Product Code MKJ
  • Cause
    Certain samaritan 300/300p pad devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an sca event if needed: issue 1 (on/off issue): the device may turn itself on and off without input from the user. when this occures, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emit.
  • Action
    HeartSine sent an Urgent: Medical Device Recall dated September 2012 to all affected customers. The letter identifed the affected product, problem and actions to be taken. A response form was included with the letter to be completed by customers and returned to the recalling firm's representative. In addition, HeartSine is providing a software upgrade to bring all users up to a more recent version of the software. For questions call 1-877-877-0147 or your service representative.The company issued an additional press release on September 13, 2013 in a further attempt to reach out to end customers that had not yet responded to the companys efforts.

Device

HeartSine Samaritan(R) 300/300P PAD devices
  • Modèle / numéro de série
    Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution and US (nationwide) in the following states: AK, AL, AP, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, and WI.
  • Description du dispositif
    HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 || Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: || Unconsciousness || Not breathing || Without circulation
  • Manufacturer
    Heartsine Technologies, Limited

Manufacturer

Heartsine Technologies, Limited
  • Adresse du fabricant
    Heartsine Technologies, Limited, 203 Airport Road West, Belfast United Kingdom
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA