BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2860872 · Received December 6, 2012

    Report

    Report Number
    3015876-2012-00878
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 20, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL REPLACED THE POWER PCB ASSEMBLY, SYSTEM PCB ASSEMBLY AND OEM PCB ASSEMBLY. PROPER DEVICE OPERATION WAS THEN OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED POWER PCB ASSEMBLY, SYSTEM PCB ASSEMBLY AND OEM PCB ASSEMBLY. THE SYSTEM PCB ASSEMBLY AND OEM PCB ASSEMBLY HAD SMOKE DAMAGE FROM THE FAILURE IN THE POWER PCB ASSEMBLY. THE POWER PCB ASSEMBLY HAD EXTENSIVE BURN DAMAGE UNDER THREE TRANSISTORS, DESIGNATORS Q6, Q7 AND Q9. MANY COMPONENTS FROM THE POWER PCB ASSEMBLY WERE MISSING BECAUSE THEY HAD MELTED OR WERE BURNED OFF. THE CAUSE OF THE REPORTED FAILURE COULD THEREFORE NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. 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

    IT WAS REPORTED TO A PHYSIO-CONTROL SERVICE REPRESENTATIVE THAT THERE WAS A BURNED ODOR COMING FROM THE CUSTOMER'S DEVICE AFTER THEY HAD PUT IT AWAY AFTER USE. THE DEVICE WOULD NOT POWER UP ANYMORE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1