BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2945142 · Received December 28, 2012

    Report

    Report Number
    3008642652-2012-03342
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 27, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY PACK WAS UNABLE TO POWER UP A TEST MONITOR AND CHARGE IN A CHARGER. THE CAUSE FOR THE POWER-UP FAILURE WAS ISOLATED TO A BLOWN BATTERY FUSE WITH HIGH RESISTANCE. THE ROOT CAUSE FOR THE BLOWN FUSE COULD NOT BE POSITIVELY IDENTIFIED. DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) HAS BEEN CONFIRMED. THE CAUSE OF THE INABILITY TO CHARGE THE BATTERIES IS CONTAMINATION ON THE BATTERY BOARD INSIDE THE CHARGER/MODEM. 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 BLOWN BATTERY FUSE OR THE CONTAMINATED BATTERY CHARGER. THE PT RECEIVED A REPLACEMENT BATTERY PACK AND REPLACEMENT BATTERY CHARGER. DEVICE MANUFACTURE DATE: SN (B)(4), 03/2010. SN (B)(4), 06/2012.

    Description of Event or Problem · 1

    A (B)(6) MALE PT'S NURSE CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER BATTERY PACK WAS NOT CHARGING WHEN PLACED IN THE BATTERY CHARGER. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK AND BATTERY CHARGER/MODEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR