BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIB

    MDR report key: 2072587 · Received April 22, 2011

    Report

    Report Number
    3015876-2011-00346
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K983393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL PROVIDED THE CUSTOMER ASSISTANCE AND PROVIDED INFO TO HAVE THE DEVICE REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LOGGED AN EVENT CODE IN THE MEMORY AND DISPLAYED THE "CALL SERVICE" MESSAGE INDICATING A POSSIBLE CRITICAL FAILURE, LOCK-UP. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIB MKJ PHYSIO-CONTROL, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA