BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1811224 · Received August 11, 2010

    Report

    Report Number
    3002158293-2010-00831
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 7, 2010
    Report Date
    August 11, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE BATTERY WAS FOUND TO HAVE A BROKEN YELLOW WIRE WITHIN THE BATTERY PACK WHERE THE WIRE ATTACHES TO THE BATTERY CELLS. THE BROKEN WIRE CAUSED AN OPEN CONNECTION BETWEEN THE BATTERY CELLS AND THE BATTERY BOARD PCA. THE ROOT CAUSE OF THE BROKEN WIRE HAS NOT BEEN DETERMINED BUT MAY HAVE BEEN CAUSED BY A SEVERE SHOCK FROM DROPPING THE PACK. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THIS BATTERY PACK HAD EXCEEDED ITS EXPECTED LIFE (>200 CYCLES). NO ADVERSE EVENT RESULTED FROM THE BROKEN INTERNAL WIRE. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE WAS HAVING TROUBLE WITH ONE OF HER BATTERIES. SHE SAID THAT THE BATTERY WAS CHARGING ALL NIGHT AND IT ONLY SHOWED ONE BAR ON THE MONITOR. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY PACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR