BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1011948 · Received March 11, 2008

    Report

    Report Number
    3002158293-2008-00098
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ZOLL LIFECOR COPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: MONITOR - 01/2008, BATTERY PACK - 11/2007, BATTERY PACK - 10/2007. DEVICE EVALUATIONS OF MONITOR, BOTH BATTERY PACKS HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE MONITOR WAS FOUND TO HAVE A DEFECTIVE BATTERY CONNECTOR. THE CONNECTOR PINS WERE BENT. THE CONNECTOR WAS REPAIRED. THE MONITOR WAS RETESTED AND THEN RESTOCKED. THE ROOT CAUSE OF THE BENT PINS IS UNKNOWN, BUT IS LIKELY DUE TO A BATTERY PACK BEING FORCED INTO A MONITOR WITH THE CONNECTORS MISALIGNED. BOTH BATTERY PACKS HAD DAMAGED CONNECTORS. THE BATTERY PACK HAD DEFECTIVE CELLS FROM MULTIPLE TIMES OF DISCHARGING COMPLETE. THE CONNECTORS WERE REPAIRED. THEN THE BATTERY PACKS WERE RETESTED AND RESTOCKED. THE ROOT CAUSE OF THE BATTERY PACK CONNECTOR DAMAGE WAS LIKELY DUE TO A BATTERY PACK BEING FORCED INTO A MONITOR WITH THE CONNECTORS MISALIGNED. THE DAMAGED CONNECTORS ON THE MONITOR AND BATTERY PACKS WERE REPLACED. NO ADVERSE EVENTS RESULTED FROM THE DAMAGED MONITOR AND BATTERY PACKS. THE PATIENT RECEIVED A REPLACEMENT MONITOR AND TWO REPLACEMENT BATTERY PACKS.

    Description of Event or Problem · 1

    THE VISITING NURSE OF A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT THE PATIENT WAS HAVING PROBLEMS WITH THE MONITOR AND BATTERY PACKS. THE RN STATED THAT WHEN A FULLY CHARGED BATTERY PACK WAS PLACED IN THE MONITOR, IT WOULD NOT START-UP ON TWO OCCASIONS. ON THE THIRD ATTEMPT, THE MONITOR SUCCESSFULLY STARTED UP. THE RN STATED THAT WHEN THE BATTERY PACK IS WIGGLED IN THE MONITOR, IT WOULD START UP. SUPPORT HAD A PATIENT SERVICES REPRESENTATIVE (PSR) VISIT THE PATIENT. THE PSR RETAINED THE PATIENT ON BATTERY PACK REMOVAL AND INSERTION. THE PSR SPECULATED THAT THE RN AND THE PATIENT MAY HAVE BEEN TRYING TO INSERT THE BATTERY PACK WHILE THE MONITOR WAS STILL IN THE HOLSTER, AND NOT COMPLETING SEATING THE BATTERY PACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR