BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2862576 · Received December 10, 2012

    Report

    Report Number
    3015876-2012-00880
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID ADVISE PHYSIO-CONTROL THAT THEY WERE GOING TO REPAIR THE DEVICE THEMSELVES BY REPLACING THE SYSTEM PCB ASSEMBLY; HOWEVER, PHYSIO HAS BEEN UNABLE TO REACH THE CUSTOMER REGARDING THE OUTCOME OF THE DEVICE REPAIR. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR REPAIR. A CONCLUSIVE 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 THAT WHEN THE DEVICE WAS POWERED ON, IT WOULD NOT COMPLETE IT'S SELF-TEST AND WOULD NOT HAVE THE ABILITY TO CONTINUE WITH NORMAL OPERATION. FURTHER USE OF THE DEVICE FOLLOWING THE SELF-TEST WAS PROHIBITED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    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