BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3023388 · Received March 1, 2013

    Report

    Report Number
    3008642652-2013-00593
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 27, 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 (POWER CORD LOOSE) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER WAS UNABLE TO POWER UP DUE TO A DAMAGED AC POWER CORD. THE ROOT CAUSE FOR THE DAMAGED POWER CORD COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED POWER CORD. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    THE HUSBAND OF A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY CHARGER CORD WAS LOOSE. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90491 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR