BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2011935 · Received February 14, 2011

    Report

    Report Number
    3002158293-2011-00162
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    December 22, 2010
    Report Date
    February 9, 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 ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (TRUNK CONNECTOR WON'T LATCH) HAS BEEN CONFIRMED. UPON EVALUATION PINS 1 AND 10 IN THE ELECTRODE BELT'S TRUNK CABLE CONNECTOR WERE BENT. THE CAUSE FOR THE BENT PINS CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE APPLIED DURING MATING. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6), MALE, PATIENT, CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BELT WOULD NOT MAKE A SECURE CONNECTION WITH THE MONITOR, AND HE HAD TO INSERT IT SEVERAL TIMES FOR IT TO LOCK IN. THE PATIENT WAS PROVIDED WITH A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR