BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1160773 · Received September 8, 2008

    Report

    Report Number
    3002158293-2008-00433
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    April 18, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE BATTERY PACK HAD A DAMAGED LOCKING TAB. THE BATTERY PACK WAS REPAIRED. IT WAS RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE DAMAGED CLIP CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO FORCIBLE REMOVAL OF THE BATTERY PACK FROM THE MONITOR WITHOUT PRESSING THE LOCKING TAB BEFORE PULLING. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE BATTERY PACK WILL NO LONGER LATCH IN THE MONITOR. HE STATED THAT IT SEEMED ALL RIGHT LAST NIGHT WHEN HE WENT TO BED, BUT WHEN HE WOKE UP THIS MORNING THE SCREEN WAS BLANK. HE STATED THAT HE TRIED TO INSERT THE BATTERY PACK INTO THE MONITOR, BUT IT WOULD NOT LATCH. HE REPORTED THAT THE OTHER BATTERY PACK FITS IN THE MONITOR SNUGGLY AND STAYS IN PLACE. SUPPORT SENT THE PATIENT A REPLACEMENT BATTERY PACK.

    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 43 YR