BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3003643 · Received February 11, 2013

    Report

    Report Number
    3008642652-2013-00349
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    April 11, 2010
    Report Date
    February 1, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOES NOT CHARGE BATTERIES) WAS CONFIRMED. UPON EVALUATION, THE BATTERY BOARD WAS DEFECTIVE. THE CAUSE OF THE INABILITY TO CHARGE THE BATTERIES IS THE DEFECTIVE BATTERY BOARD. THE ROOT CAUSE OF THE DEFECTIVE BATTERY BOARD COULD BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY BOARD INSIDE CHARGER/MODEM. THE PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT ON (B)(6) 2010 TO REPORT THAT WHEN HE PUTS HIS BATTERY INTO HE CHARGER, IT WILL NOT CHARGE. A NON-REPORTABLE DECISION WAS MADE ON (B)(6) 2010 AS THE EQUIPMENT HAD NOT BEEN RETURNED AND THE ALLEGED DEFICIENCY COULD NOT BE FURTHER INVESTIGATED OR CONFIRMED. A RE-QUERY OF THE DATA ON (B)(6) 2013, REVEALED THAT THE CHARGER/MODEM HAD BEEN RETURNED ON (B)(4) 2010 AND A REPORTABLE MALFUNCTION WAS DISCOVERED ON (B)(4) 2010. THE PATIENT HAD BEEN ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60483 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR