BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4181241 · Received August 4, 2014

    Report

    Report Number
    3008642652-2014-02366
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 31, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 (BATTERY WASN'T RECOGNIZED AND DID NOT FIT IN MONITOR) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE BATTERY PACK WAS UNABLE TO POWER UP A MONITOR OR CHARGE. THE CAUSE FOR THE FAILURE TO BATTERY PCA BOARD AND CELLS. THE CONTAMINATION HAD CAUSED THE CELLS TO SWELL INSIDE THE HOUSING RESULTING IN AN INABILITY TO LATCH. THE ROOT CAUSE FOR THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY INGRESS OF AN UNK LIQUID. 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 CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY PACK SN 86110217 WAS NOT BEING RECOGNIZED IN HIS CHARGER AND THE SAME BATTERY PACK WAS STICKING IN HIS MONITOR. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453801 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR