BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2890868 · Received November 21, 2012

    Report

    Report Number
    3008642652-2012-03061
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 11, 2012
    Report Date
    November 19, 2012
    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) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (BATTERY MAY BE DEFECTIVE) HAS BEEN CONFIRMED. AS RECEIVED, THE BATTERY WOULD NOT CHARGE WHEN PLACED N THE CHARGER, BUT DID POWER ON A MONITOR. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. 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 WILE ASSISTING A 93 (B)(6) FEMALE PT TO REPORT THAT WHEN BATTERY PACK SN (B)(4) WAS PLACED IN THE MONITOR, THE MONITOR DISPLAYED THAT THE BATTERY MAY BE DEFECTIVE. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR