BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 724238 · Received June 1, 2006

    Report

    Report Number
    3002158293-2006-00074
    Event Type
    Malfunction
    Date Received
    June 1, 2006
    Date of Event
    April 25, 2006
    Report Date
    June 1, 2006
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MONITOR 04/2006. BATTERY PACK- 08/2005. EVALUATION: DEVICE EVALUATION OF MONITOR AND BATTERY PACK HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. SEVERAL OF THE CONTACTS IN THE BATTERY CONNECTOR WITHIN THE MONITOR WERE DAMAGED. IN ADDITION, BOTH BATTERY PACKS HAD DAMAGE TO THE CONNECTOR. THE CAUSE OF THE BENTS CONTACTS WAS LIKELY A CONNECTOR MISALIGNMENT BETWEEN A BATTERY PACK AND THE MONITOR. THE ROOT CAUSE OF THE CONNECTOR MISALIGNMENT CANNOT BE POSITIVELY IDENTIFIED. THE DAMAGED CONNECTORS WILL BE REPLACED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR. THE PT RECEIVED A REPLACEMENT MONITOR AND BATTERY PACKS.

    Description of Event or Problem · 1

    A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT A BENT BATTERY CONTACT IN HIS MONITOR. THE MONITOR WAS NOT MAKING PROPER CONTACT WITH THE BATTERY PACK AND WASN'T WORKING. HE REPORTS THAT HE WAS ABLE TO BEND THE CONTACT, SO THAT THE MONITOR IS NOW FUNCTIONING. A REPLACEMENT MONITOR WAS PROVIDED TO THE PT. IN A FOLLOW-UP CALL, SUPPORT REQUESTED THAT THE 2 ORIGINAL BATTERY PACKS USED WITH THE MONITOR ALSO BE RETURNED FOR EVALUATION ONCE THE REPLACEMENT EQUIPMENT ARRIVES.

    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 52 YR