BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2843830 · Received October 26, 2012

    Report

    Report Number
    3008642652-2012-02803
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 9, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PACK WAS UNABLE TO RECHARGE OR POWER UP A TEST MONITOR. THE BATTERY VOLTAGE WAS 1.88V. THE ROOT CAUSE FOR THE DEFECTIVE BATTERY PACK COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DEFECTIVE BATTERY CELLS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(4) DISTRIBUTOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A PT'S BATTERY PACK WAS DEFECTIVE. THE PT RECEIVED 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 NA