BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2251283 · Received August 12, 2011

    Report

    Report Number
    3008642652-2011-00435
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 6, 2011
    Report Date
    August 10, 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 ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ARRYTHMIA ALARMS) HAS BEEN CONFIRMED. UPON EVAL, ECG D AND ECG A HAD LOW OUTPUT FROM THE OP AMP WHICH PRODUCED NOISE ARTIFACT THAT CAUSED THE ARRHYTHMIA ALARMS. THE ROOT CAUSE OF THE LOW ECG OUTPUT WAS A SHORT IN THE FEEDBACK LOOP TO THE OP AMP. NO ADVERSE EVENT RESULTED FROM SHORT IN THE FEEDBACK LOOP TO THE OP AMP. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE WAS RECEIVING A LOT OF HIGH SIREN ALARMS. THE PT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR