BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1053472 · Received May 28, 2008

    Report

    Report Number
    3002158293-2008-00227
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 27, 2008
    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

    DEVICE EVAL SUMMARY: DEVICE EVAL OF MONITOR HAD BEEN COMPLETED. THE REPORTED PROBLEM (DEVICE WOULD NOT START UP) WAS CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM WAS A SHORTED TANTALUM CAPACITOR (C10) ON THE DEFIBRILLATOR PCA WITHIN THE MONITORS. THE CAPACITOR HAD DEVELOPED AN INTERNAL SHORT CIRCUIT WHICH, IN TURN, SHORTED THE (+) AND (-) BATTERY INPUTS AND RESULTED IN EXCESSIVE CURRENT DRAW ACROSS C10. THE MONITOR ALSO HAD THE 3 AND 5 VOLT POWER SUPPLIES ON THE MONITOR SHORTED. R46 WAS BURNT AND IT WAS NOTICED THAT THERE WERE "DISCHARGE PROFILE FAULT" FLAGS BEFORE THE MONITOR WOULD NOT POWER UP. THE MONITOR WAS CHARGING THE CAPACITORS WHEN IT FAILED. THERE IS NO EVIDENCE THAT THE PT WAS TREATED. THE ELECTRODE BELT WAS FULLY FUNCTIONAL. IT DID NOT HAVE GEL RELEASE. THERE WERE NO BURNS ON THE PT. THE ROOT CAUSE OF THE FAILURE IS UNKNOWN, BUT USUALLY OCCURS WITH LIQUID INGRESS. THE MONITOR WAS SCRAPPED. NO ADVERSE EVENT RESULTED FROM THE MONITOR FAILURE. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A FEMALE PT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT SHE WAS SITTING ON THE SIDE OF HER BED AND THE SYSTEM SHOCKED HER. THE PT STATED THAT SHE HAD A PIECE OF PAPER IN HER AND IT HAD FLEW ACROSS THE ROOM. THE PT DENIED TACTILE ALARM OR VERBAL ALARMS. SUPPORT ASKED THAT THE PT PLACE THE BATTERY BACK INTO THE MONITOR TO DOWNLOAD BUT THE BATTERY WILL NOT START THE MONITOR. SUPPORT HAD PT TRY THE SECOND BATTERY THAT ALSO WOULD NOT START THE MONITOR. SUPPORT ASKED IF THE PT HAD ANY BLUE GEL ON HER AND SHE HAD HER SON CHECK AND DENIED ANY BLUE GEL. SUPPORT EXPLAINED TO THE PT THAT SHE WILL BE UNPROTECTED AND THAT SHE SHOULD CONTACT HER PHYSICIAN. SUPPORT WILL ARRANGE A PT SERVICES REPRESENTATIVE (PSR) TO DOWNLOAD OR SWAP THE MONITOR.

    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 68 YR