BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2241529 · Received August 10, 2011

    Report

    Report Number
    3008642652-2011-00402
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 8, 2011
    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 EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER NOT WORKING) HAS BEEN CONFIRMED. UPON EVAL, THE BATTERY CHARGER/MODEM WOULD NOT CHARGE BATTERIES. THE BATTERY CONNECTOR WAS CONTAMINATED AND CORRODED. THE ROOT CAUSE OF THE CONTAMINATION CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM. DEVICE EVAL OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WON'T CHARGE) HAS BEEN CONFIRMED. UPON EVAL, THE BATTERY WOULD NOT CHARGE IN THE BATTERY CHARGER NOR POWER UP A MONITOR. THE ROOT CAUSE OF THE BATTERY MALFUNCTION WAS CONTAMINATION FROM THE CORRODED CHARGER/MODEM (SN (B)(4)) BATTERY CONNECTOR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK. CHARGER/MODEM SN (B)(4). BATTERY PACK SN (B)(4) - MFG 06/2010.

    Description of Event or Problem · 1

    THE NIECE OF A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY CHARGER WAS READING "PLEASE INSERT BATTERY" EVEN THOUGH THE BATTERY WAS IN THE CHARGER PROPERLY. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK AND A REPLACEMENT 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 78 YR