BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2111028 · Received May 17, 2011

    Report

    Report Number
    3015876-2011-00399
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 18, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE SYSTEM AND MEMORY PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED SYSTEM AND MEMORY PCB ASSEMBLY; HOWEVER, A CONCLUSIVE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PT CARE, THE CUSTOMER'S DEVICE DISPLAYED "SERVICE" ACROSS THE SCREEN AND POWERED ITSELF OFF TWO SEPARATE TIMES. UPON INITIAL EVAL OF THE DEVICE BY PHYSIO-CONTROL, SEVERAL FAULT CODES WERE ALSO DISCOVERED, WHICH ARE POTENTIALLY RELATED TO THE REPORTED FAILURE. THE PT DID NOT SUFFER ANY ADVERSE EFFECTS FROM A RESULT OF THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK