BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221517 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01747
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 (NOT HOLDING CHARGE) WAS CONFIRMED. UPON INVESTIGATION, THE BATTERY WAS UNABLE TO RECHARGE OR POWER UP A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO MISMATCHED VOLTAGE OF THE BATTERY TRI-CELLS (4.120V, 0.116V, 0.419V). THE ROOT CAUSE FOR THE MISMATCHED TRI-CELLS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT'S NEPHEW CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT ONE OF HIS BATTERIES WASN'T HOLDING A CHARGE. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301739 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR