BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3913817 · Received July 3, 2014

    Report

    Report Number
    3015876-2014-00766
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE ANALYSIS CENTER EVALUATED THE DEVICE, BUT COULD NOT REPRODUCE ANY POWER ON DISCREPANCIES. IT WAS OBSERVED THAT THE DEVICE'S BATTERY PLUG WIRE HARNESS CAUSED THE BATTERY TO INTERMITTENTLY NOT COMMUNICATE WITH THE DEVICE. THE FAILURE ANALYSIS CENTER FURTHER EVALUATED THE BATTERY PLUG WIRE HARNESS AND OBSERVED THAT SOCKET 4 OF THE BATTERY PLUG WIRE HARNESS WAS BENT OPEN AND CAUSED AN INTERMITTENT OPEN CONNECTION TO THE DEVICE. THE DEVICE COULD NOT COMMUNICATE WITH THE BATTERY AND SET THE BATTERY CHARGE INDICATOR TO ONE BAR AND CAUSED THE DEVICE TO PROMPT 'REPLACE BATTERY'.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE BUT COULD NOT VERIFY THE REPORTED FAILURE. THE DEVICE SHOWS OK AND INDICATED MORE THAN 75% OF BATTERY CHARGE FOR BOTH BATTERIES THAT WERE RETURNED WITH THE DEVICE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. A CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A PHYSIO-CONTROL SALES REPRESENTATIVE THAT THEIR DEVICE COULD NOT BE POWERED ON. THE DEVICE HAD EARLIER BEEN USED ON A PATIENT. AT THAT TIME THE DEVICE HAD DISPLAYED A "REPLACE BATTERY" PROMPT WHEN IT WAS POWERED ON. HOWEVER, THE DEVICE FUNCTIONED NORMALLY THROUGHOUT THE EVENT, AND THERE WAS NO NEED TO DELIVER A DEFIBRILLATION SHOCK TO THE PATIENT. SOMETIME AFTER THE EVENT, THE CUSTOMER TRIED TO POWER ON THE DEVICE AGAIN. DESPITE THE BATTERY INDICATOR SHOWING 1 BAR, THE DEVICE WAS NOT ABLE TO POWER ON ANYMORE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT OF THE DEVICE NOT POWERING ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390604 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1