BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1882484 · Received October 21, 2010

    Report

    Report Number
    3002158293-2010-01080
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    March 30, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MONITOR SN (B)(4): 11/2008. BATTERY PACK SN (B)(4): 08/2008, BATTERY PACK SN (B)(4): 10/2008. DEVICE EVAL SUMMARY: DEVICE EVALUATIONS OF BATTERY PACKS SN (B)(4) AND SN (B)(4) AND SN (B)(4) HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE DISCHARGED BATTERY PACKS WAS DEFECTIVE CELLS WITHIN THE BATTERY PACK. ONE OF THE CELLS IN EACH BATTERY PACK HAD RESIDUE/CORROSION ON THEM. THE SOURCE OF THE RESIDUE/CORROSION HAS NOT BEEN POSITIVELY IDENTIFIED BUT IS LIKELY ELECTROLYTE FROM A LEAKING CELL. THE ROOT CAUSE OF THE LEAKING CELL WAS NOT POSITIVELY IDENTIFIED. THE CAUSES OF THE MONITOR'S STARTUP PROBLEM WERE LOCKED UP DIGITAL SIGNAL PROCESSOR (DSP, U300 COMPONENT) AND PROGRAMMABLE LOGIC DEVICE (PLD). THIS FAULT ALSO CAUSED THE TACTILE ALARM ISSUE. ONCE THE DSP AND PLD WERE REPROGRAMMED, THE MONITOR FUNCTIONED PROPERLY AND THE TACTILE ALARM PROBLEMS WERE SOLVED. THE ROOT CAUSE FOR THE DSP AND PLD TO LOSE INTERNAL PROGRAMMING CANNOT POSITIVELY BE IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACKS OR MONITOR. THE PT RECEIVED TWO REPLACEMENT BATTERY PACKS AND A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    ZOLL LIFECOR CUSTOMER SUPPORT REVIEWED THE DOWNLOAD OF A (B)(6) PT WHICH REVEALED SEVERAL ABNORMAL SHUTDOWNS. CUSTOMER SUPPORT CONTACTED THE PT TO DISCUSS THE MONITOR ISSUE. THE PT'S SON STATED THAT ONE OF THE PT'S BATTERIES WOULD NOT TURN THE SYS ON AND THE OTHER ONE IS UNABLE TO HOLD A CHARGE. SUPPORT ISSUED THE PT TWO REPLACEMENT BATTERY PACKS AND A REPLACEMENT MONITOR.

    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 72 YR