BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2920654 · Received December 7, 2012

    Report

    Report Number
    3008642652-2012-03190
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 30, 2012
    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 MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE MONITOR WOULD NOT POWER ON. THE CAUSE OF THE INABILITY TO POWER ON IS A DAMAGED BATTERY CONNECTOR (J1) ON THE DEFIBRILLATOR BOARD, PREVENTING THE MONITOR FROM CONTACTING THE BATTERY PACK. THE ROOT CAUSE OF THE DAMAGED BATTERY CONNECTOR CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY INDUCED FROM EXCESSIVE FORCE WHEN THE BATTERY WAS MATED WITH THE MONITOR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CONNECTOR. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR WOULD NOT POWER ON. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR