BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3830421 · Received May 14, 2014

    Report

    Report Number
    3008642652-2014-01462
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 12, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 (WON'T CONNECT TO POWER SUPPLY) WAS CONFIRMED. UPON INVESTIGATION THE POWER SUPPLY CONNECTOR WAS BENT, PREVENTING IT FROM CONNECTING TO AND POWERING UP THE BATTERY CHARGER/MODEM. THE ROOT CAUSE FOR THE BENT POWER SUPPLY CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE BENT POWER SUPPLY CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER POWER SUPPLY BRICK WOULDN'T CONNECT TO HIS CHARGER. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/,MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288107 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR