BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3033145 · Received March 1, 2013

    Report

    Report Number
    3008642652-2013-00600
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 28, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CONNECTOR DAMAGED) HAS BEEN CONFIRMED. UPON INVESTIGATION THE CHARGER'S WHITE WIRE WAS PULLED OUT OF THE POWER SUPPLY CONNECTOR, WHICH PREVENTED THE CHARGER FROM CHARGING A BATTERY. THE ROOT CAUSE FOR DAMAGED CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED BUT LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A WIFE OF A (B)(6) MALE PT CALLED A ZOLL PT SVC REP (PSR) TO REPORT THAT THE PT'S BATTERY CHARGER CONNECTOR WAS DAMAGED. THE PT WAS ISSUE A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90262 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR