BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2212061 · Received July 8, 2011

    Report

    Report Number
    3008642652-2011-00165
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 5, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WON'T POWER UP) HAS BEEN CONFIRMED. UPON EVAL THE COMPUTER ANALOG BOARD AND DEFIBRILLATOR BOARD WERE DAMAGED, PREVENTING THE MONITOR FROM POWERING UP. THE CAUSE FOR THE DAMAGED BOARDS CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF MECHANICAL SHOCK FROM A DROP. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BOARDS. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    THE MOTHER OF A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR WOULD NOT POWER ON FURTHER THAN THE SPLASH SCREEN. THE PT WAS ISSUED A REPLACEMENT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR