BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2031505 · Received March 21, 2011

    Report

    Report Number
    3002158293-2011-00341
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 13, 2011
    Report Date
    March 18, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. UPON RECEIPT THE MONITOR WOULD NOT POWER UP. UPON EVALUATION, IT WAS DISCOVERED THAT MONITOR HAD A DEFECTIVE COMPONENT (C9). THE C9 COMPONENT IS AN EQUIVALENT SERIES RESISTANCE CAPACITOR LOCATED ON THE BIPHASIC DEFIBRILLATOR PCA BOARD OF THE MONITOR. THE DEFECTIVE C9 SHORTED THE BATTERY CONNECTOR TO GROUND, BLOWING THE FUSE OF ANY BATTERY PACK INSERTED. THE CAUSE OF THE MONITOR NOT POWERING UP WAS THE BATTERIES BEING DISCHARGED DUE TO THE DEFECTIVE CAPACITOR. THE ROOT CAUSE OF THE DEFECTIVE CAPACITOR CANNOT BE POSITIVELY IDENTIFIED, BUT WAS MOST LIKELY RANDOM COMPONENT FAILURE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CAPACITOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT SHE HEARD A POPPING SOUND FROM HER MONITOR AND THEN HER MONITOR WOULD NOT POWER UP. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.

    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 57 YR