BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080833 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-00985
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 5, 2013
    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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON MONITOR / WILL NOT CHARGE) WAS CONFIRMED. AS RECEIVED, THE BATTERY WOULD NOT CHARGE OR POWER ON A MONITOR. UPON EVALUATION, THERE WAS CORROSION ON THE PCA BOARD INSIDE THE BATTERY PACK. THE CAUSE OF THE INABILITY TO CHARGE AND POWER ON A MONITOR IS THE CORROSION ON THE PCA BOARD. THE CAUSE OF THE CORROSION IS LIQUID CONTAMINATION. THE ROOT CAUSE OF THE CONTAMINATION CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY INGRESS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A PT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) FEMALE PT TO REPORT THAT ONE OF THE PT'S BATTERIES WOULD NOT POWER ON THE MONITOR AND WOULD NOT CHARGE WHEN PUT INTO A CHARGER. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157866 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR