BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3830442 · Received May 14, 2014

    Report

    Report Number
    3008642652-2014-01448
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER FAULTS) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS UNABLE TO RECOGNIZE BATTERY PACKS. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A CONTAMINATED BATTERY BOARD. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNK LIQUID. DEVICE EVALUATION OF BATTERY PACK SN 86034387 WAS COMPLETED. THE REPORTED PROBLEM (BATTERY FAULTS) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY PACK WAS UNABLE TO RECHARGE OR POWER UP A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A FRACTURED PAD UNDER COMPONENT P4 OF THE BATTERY PCA BOARD. THE ROOT CAUSE FOR THE DAMAGE COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE BATTERY IMPACTING A HARD SURFACE. NO ADVERSE EVENT RESULTED FROM THE BATTERY IMPACTING A HARD SURFACE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM AND BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM AND BATTERY PACK. DEVICE MFG DATE: BATTERY CHARGER/MODEM, SN (B)(4), MANUFACTURED 06/2012. BATTERY PACK, SN (B)(4), MANUFACTURED 05/2012.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HE WAS RECEIVING BATTERY CHARGER FAULTS. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM AND A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288085 LIFEVEST WCD 4000 SYS WEABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR