BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1900086 · Received November 11, 2010

    Report

    Report Number
    3002158293-2010-01182
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    July 27, 2010
    Report Date
    November 8, 2010
    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

    FOLLOW-UP. THIS REPORT IS A CORRECTION TO THE INITIAL MDR 3002158293-2010-00414. "(B)(6) 2009" WAS CHANGED TO ""(B)(6) 2010. ""(B)(6) 2010" WAS CHANGED TO ""(B)(6) 2010." DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER "(B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE BATTERY CHARGER WAS NOT FUNCTIONAL AND WOULD NOT CHARGE THE PT'S BATTERY PACKS. THE CAUSE ON THE NON-FUNCTIONAL CHARGER WAS AN INTERMITTENT CONNECTOR FROM THE POWER BRICK TO THE CHARGER. THE ROOT CAUSE OF THE INTERMITTENT CONNECTOR CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE INTERMITTENT BATTERY CHARGER. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT SVC TO REPORT THAT HE WAS HAVING TROUBLE WITH HIS BATTERY CHARGER. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR