BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1062778 · Received June 17, 2008

    Report

    Report Number
    3002158293-2008-00276
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 5, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: MONITOR - 12/2007. BATTERY PACK - 01/2008. BATTERY PACK - 10/2007. BATTERY PACK - 12/2007. BATTERY PACK - 12/2007. BATTERY CHARGER - 05/2007. BATTERY CHARGER - 03/2008. DEVICE EVAL SUMMARY: DEVICE EVALUATIONS OF MONITOR, BATTERY PACK, BATTERY PACK, BATTERY PACK, BATTERY PACK, BATTERY CHARGER, AND BATTERY CHARGER HAVE BEEN COMPLETED. THE REPORTED PROBLEM (DEVICE WOULD NOT START UP) WAS CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM WAS A POWER SUPPLY FAILURE WITHIN THE MONITORS. R46 AND R45 WERE BURNT AND IT WAS NOTICED THAT THERE WERE "DISCHARGE PROFILE FAULT" FLAGS BEFORE THE MONITOR WOULD NOT POWER UP. THE PT EXPERIENCED MANY ARRHYTHMIA ALARMS ON THE DAY THAT THE MONITOR HAD FAILED. HE WAS USING THE RESPONSE BUTTONS, BUT THE CAPACITITORS HAD CHARGED AND DISCHARGED MANY TIMES THAT DAY. THERE IS NO EVIDENCE THAT THE PT WAS TREATED. THE ROOT CAUSE OF THE FAILURE IS UNK, BUT MAY BE DUE TO EXCESSIVE CHARGING, AND DISCHARGING. THE MONITOR HAD ALL BOARDS REPLACED. THE MONITOR WAS RETESTED AND RESTOCKED. ALL FOUR BATTERY PACKS HAD BLOWN FUSES. THE ROOT CAUSE OF THE BLOWN FUSES WAS FROM THE POWER SUPPLY FAILURE WITHIN THE MONITOR. THEY WERE REPLACED, RETESTED AND RESTOCKED. BOTH BATTERY CHARGERS WERE FULLY FUNCTIONAL. THEY WERE RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE MONITOR FAILURE. THE PT RECEIVED A REPLACEMENT MONITOR, BATTERY CHARGER AND TWO BATTERY PACKS.

    Description of Event or Problem · 1

    A LIFECOR PT SERVICES REP (PSR) CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT A MALE PT'S MONITOR WOULD NOT POWER UP. SHE STATED THAT THE BATTERY PACK WHEN REMOVED FROM THE MONITOR SHOWED A "BATTERY PACK WHEN REMOVED FROM THE MONITOR SHOWED A "BATTERY CHARGER FAULT" LED WHEN PLACED ON THE BATTERY CHARGER. SUPPORT HAD THE PSR SWAP BATTERIES, AND THE OTHER WILL NOT BOOT THE MONITOR, AND ALSO SHOWS A CHARGER FAULT ON THE BATTERY CHARGER. SUPPORT IS HAVING ANOTHER PSR BRING REPLACEMENT BATTERY PACKS TO THE PT. THE SECOND PSR BROUGHT THE PT NEW EQUIPMENT. TWO BATTERY PACKS WERE PLACED INTO THE OLD MONITOR AND NOW THERE ARE FOUR BATTERY PACKS THAT SHOW PROBLEMS ON TWO BATTERY CHARGERS AND NEITHER OF THE MONITORS WILL START. THE PSR GAVE THE PT A REPLACEMENT MONITOR, BATTERY CHARGER AND TWO BATTERY PACKS.

    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 69 YR