Events

Rappel de OneStep CPR Complete

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 ZOLL Medical Corporation.

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
    79204
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0977-2018
  • Date de mise en oeuvre de l'événement
    2017-08-04
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161639
  • 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
    A portion of one lot of zoll onestep complete electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the zoll r series defibrillator. defective electrodes will display pediatric pads in use on the r series defibrillator. using the affected product with the m series defibrillator poses no risk.
  • Action
    Zoll sent an Urgent Device Correction letter dated August 4, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The following actions should be taken until the affected electrodes are removed from use: 1. Alert staff to the possibility of this occurrence. 2. Instruct staff to inspect the lot code on the electrode package and remove affected lot 2517A from use. 3. Inform users that if they encounter this situation in the process of defibrillating an adult patient, they should set the defibrillator energy level manually. 4. Complete the attached form and return to ZOLL for replacement electrodes. ZOLL will be replacing the effected lot of the electrodes with properly configured electrodes. For questions contact technical support at 1-800-348-9011 or 1-978-421-9460.

Device

OneStep CPR Complete
  • Modèle / numéro de série
    Lot Number: 2517A (Expiration date: 2019-06-24)
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and in the countries of Canada.
  • Description du dispositif
    OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single electrodes, UDI: 10847946016279) and 8900 0224 01 (single electrode, UDI: 00847946016272) || Product Usage: || Intended Use: Defibrillation, Cardioversion, Noninvasive Pacing, EGG Monitoring, CPR Sensor. For use with ZOLL¿ Defibrillators: R Series, M Series. By Trained Personnel only, Including: Physicians, Nurses, Paramedics, Emergency Medical Technicians, Cardiovascular Laboratory Technicians.
  • Manufacturer
    ZOLL Medical Corporation

Manufacturer

ZOLL Medical Corporation
  • Adresse du fabricant
    ZOLL Medical Corporation, 269 & 271 Mill Road, Chelmsford MA 01824
  • Société-mère du fabricant (2017)
    Asahi Kasei Corp.
  • Source
    USFDA