BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 2830366 · Received November 13, 2012

    Report

    Report Number
    3015876-2012-00839
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER MODULE AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER MODULE AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE. FOLLOW-UP DATA: PHYSIO-CONTROL FURTHER EXAMINED THE REMOVED POWER SUPPLY ASSEMBLY WHERE IT WAS VERIFIED THAT THERE WAS ONLY NO AC OPERATION. PHYSIO DETERMINED THAT THE CAUSE OF THE NO AC OPERATION FAILURE WAS AN INTEGRATED CIRCUIT (IC) CHIP, DESIGNATOR IC1, OF THE POWER SUPPLY MODULE WHICH IS LOCATED ON THE POWER SUPPLY ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT OPERATE ON AC OR DC POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1