BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3940431 · Received April 17, 2014

    Report

    Report Number
    3008642652-2014-01167
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORT PROBLEM (DOES NOT LIGHT UP) WAS CONFIRMED. UPON EVALUATION, THERE WAS CONTAMINATION ON THE BATTERY BOARD. THE CAUSE OF THE INABILITY TO RECOGNIZE A BATTERY PACK IS THE CONTAMINATION. THE ROOT CAUSE OF THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY LIQUID INGRESS OF AN UNK CONTAMINANT. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATED CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A PT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) MALE PATIENT TO REPORT THAT THE PT'S CHARGE/MODULE WOULD NOT 'LIGHT UP'. THE PT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236051 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERGER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR