BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1011959 · Received March 11, 2008

    Report

    Report Number
    3002158293-2008-00096
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    ---
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT HAS BEEN COMPLETED. THE PROBLEM WAS CONFIRMED. UPON FURTHER INSPECTION, ELECTRODE BELT HAD PINS THAT WERE BENT INSIDE THE CONNECTOR. THE ROOT CAUSE OF THE BENT PINS WAS PROBABLY EXCESSIVE FORCE APPLIED TO THE CONNECTOR DURING MATING. THE CONNECTOR WAS FORCED INTO THE MONITOR WHICH DEFEATED THE CONNECTOR KEYING MECHANISM AND ALLOWED THE PINS TO MISALIGN WITH THE MATING SOCKETS. THE CONNECTOR NUT AND THE CONNECTOR BODY ALSO WERE DAMAGED. THE DAMAGED ELECTRODE BELT CONNECTOR WAS REPLACED. THE ELECTRODE BELT WAS RETESTED AND THEN RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE BENT PINS. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE PATIENT SERVICES REPRESENTATIVE (PSR) OF A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE ELECTRODE BELT HAD BENT PIN IN THE CONNECTOR. THE PSR HAD VISITED AND RETRAINED THE PATIENT. THE PATIENT HAS BEEN CAUTIONED ABOUT NOT DISCONNECTING THE ELECTRODE BELT FROM THE MONITOR. SUPPORT SENT THE PATIENT A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR --- ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR