BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2050122 · Received April 5, 2011

    Report

    Report Number
    3002158293-2011-00372
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER FAULTS) HAS BEEN CONFIRMED. THE CAUSE OF THE BATTERY NOT FULLY CHARGING WAS A BROKEN WHITE WIRE WITHIN THE BATTERY PACK WHERE THE WIRE ATTACHES TO THE BATTERY CELLS. THE ROOT CAUSE OF THE BROKEN WIRE HAS NOT BEEN DETERMINED BUT MAY HAVE BEEN CAUSED BY A SEVERE SHOCK FROM DROPPING THE PACK. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY. THE PT REC'D A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    ZOLL CUSTOMER SUPPORT REVIEWED THE DOWNLOAD OF A (B)(6) FEMALE PT WHICH REVEALED SEVERAL BATTERY CHARGER FAULTS. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR