BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1935086 · Received December 6, 2010

    Report

    Report Number
    3015876-2010-01329
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    July 12, 2010
    Report Date
    August 23, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS DETERMINED THAT THE CAUSE WAS AN IC CHIP, DESIGNATOR U61, ON THE SYSTEM CONTROLLER PCB ASSEMBLY. THIS FAILURE CAUSED THE DEVICE TO CONSTANTLY RESET. THE SYSTEM CONTROLLER PCB ASSEMBLY WAS REPLACED AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WAS DISPLAYING A SERVICE INDICATOR AND WOULD NOT HOLD ANY USER SETTING CONFIGURATIONS. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVAL BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE WOULD CONSTANTLY RESET ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA