BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 2903991 · Received January 9, 2013

    Report

    Report Number
    3015876-2013-00026
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL REPLACED THE POWER SUPPLY ASSEMBLY WHICH RESOLVED THE REPORTED FAILURE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EXAMINED THE REMOVED POWER SUPPLY ASSEMBLY AND VERIFIED THAT THERE WAS NO AC OPERATION. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS AN ELECTRICAL SHORT THROUGH FET TRANSISTORS, DESIGNATORS Q1 AND Q2. IT WAS ALSO OBSERVED THAT A FUSE, DESIGNATOR F1, WAS OPEN AS A RESULT OF THE SHORTED FET TRANSISTORS WHICH WOULD NOT ALLOW 12-VOLT OUTPUT AND, AS A RESULT, WOULD NOT CHARGE THE BATTERY.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE REPORTED AC AND DC POWER FAILURE. PHYSIO OBSERVED THAT THE DEVICE FUNCTIONED NORMALLY IN DC MODE, BUT WOULD NOT FUNCTION IN AC MODE. 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 THAT THEIR DEVICE WOULD NOT COMPLETE ITS BOOT UP CYCLE COMPLETELY AND THEN WOULD LOSE POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11980 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E

    Patients

    Seq Age Sex Outcome Treatment
    1