BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3173235 · Received June 7, 2013

    Report

    Report Number
    3008642652-2013-01461
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 29, 2013
    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 EVAL SUMMARY: DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER POWER CONNECTOR PROBLEM) WAS CONFIRMED. UPON RECEIPT, THE POWER BRICK WAS DEFECTIVE. THE CAUSE WAS A GROUND PRONG THAT WAS BROKEN OFF THE POWER BRICK. THE ROOT CAUSE FOR THE BROKEN POWER BRICK PRONG WAS UNABLE TO BE POSITIVELY DETERMINED, BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BATTERY CHARGER POWER BRICK PRONG. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A PT SERVICE REP CONTACTED ZOLL CUSTOMER SUPPORT WHILE FITTING A (B)(6) MALE PT TO REPORT THAT THE GROUND PIECE WAS BROKEN OFF THE BATTERY CHARGER CABLE. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253586 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR