BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2960362 · Received January 11, 2013

    Report

    Report Number
    3008642652-2012-03385
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 22, 2012
    Report Date
    December 27, 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) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY DEFECTIVE) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY WAS UNABLE TO RECHARGE OR POWER UP A TEST MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A BLOWN BATTERY FUSE. THE ROOT CAUSE FOR THE BLOWN FUSE COULD NOT BE POSITIVELY IDENTIFIED. DEVICE EVALUATION OF BATTERY PACK SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (BATTERY DEFECTIVE) WAS CONFIRMED. AS RECEIVED, THE BATTERY WOULD NOT CHARGE OR POWER ON A MONITOR. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVALUATION. DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. UPON INVESTIGATION CAPACITOR C9 ON THE MONITOR C/A BOARD WAS SHORTED AND THE PAD UNDER THE CAPACITOR WAS LIFTED. THE ROOT CAUSE FOR THE SHORTED CAPACITOR AND LIFTED PAD COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACKS AND MONITOR. THE PATIENT RECEIVED REPLACEMENT BATTERY PACKS AND A MONITOR. DEVICE MANUFACTURE DATE: (B)(4).

    Description of Event or Problem · 1

    A (B)(6) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A MALE PATIENT'S BATTERY PACKS WEREN'T WORKING AND THE PATIENT'S MONITOR WOULD NOT POWER UP. THE PATIENT WAS ISSUED REPLACEMENT BATTERY PACKS AND A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17324 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA