BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1030433 · Received April 16, 2008

    Report

    Report Number
    3002158293-2008-00163
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 5, 2008
    Report Date
    April 15, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVALUATION OF BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE BATTERY PACK HAD A DAMAGED BATTERY CONNECTOR. THE ROOT CAUSE OF THE DAMAGE CANNOT BE POSITIVELY IDENTIFIED BUT APPEARS TO BE THE RESULT OF THE BATTERY PACK BEING FORCED INTO A MISALIGNED MONITOR CONNECTOR. THE CONNECTOR WAS REPAIRED. THE BATTERY PACK WAS RETESTED AND THEN RESTOCKED. THE DAMAGED CONNECTOR ON THE BATTERY PACK WAS REPLACED. NO ADVERSE EVENTS RESULTED FROM THE DAMAGED BATTERY PACK. THE PT REC'D A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    THE NURSE OF A MALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT WHEN SHE WENT TO REPLACE THE BATTERY PACKS THIS EVENING, THE BATTERY PACK WOULD NOT POWER UP THE MONITOR. WHEN SHE REMOVED THE BATTERY PACK FROM THE MONITOR, SHE NOTICED SOME LINT ON THE CONNECTOR. SHE STATED THAT WHEN SHE PLACED THIS BATTERY PACK ON THE BATTERY CHARGER IT WOULD NOT CHARGE. SHE STATED THAT THE OTHER BATTERY PACKS SEEMS TO BE FUNCTIONING NORMALLY. SUPPORT SENT THE PT 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 44 YR