BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1082865 · Received July 25, 2008

    Report

    Report Number
    3002158293-2008-00326
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    May 16, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, THE 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 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 DOCTOR OF A FEMALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PATIENT ENTERED THE HOSPITAL LAST NIGHT FOR A NON-CARDIAC RELATED EVENT. HE STATED THAT THE VEST WAS REMOVED FROM THE PATIENT FOR A WHILE AND WHEN THEY WENT TO PUT THE VEST BACK ON THE PATIENT, THE ELECTRODE BELT WOULD NOT CONNECT TO THE MONITOR. A PATIENT SERVICES REPRESENTATIVE (PSR) WAS SENT TO THE PATIENT TO REPLACE THE 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 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR