BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LP12

    MDR report key: 1171985 · Received September 22, 2008

    Report

    Report Number
    MW5008377
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    July 7, 2007
    Report Date
    September 22, 2008
    Manufacturer
    MEDTRON PHYSIO CONTROL
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WORKING A TRAUMA ARREST PATIENT THE LP12 MONITOR BEGAN TO SHOW NOTHING BUT ARTIFACT ON THE SCREEN IN "PADDLE MODE" ALTHOUGH THE PATIENT HAD BEEN IN PEA IN LEAD II. THE MONITOR WAS SHUT OFF X 2-3 TIMES BUT REMAINED IN THIS MODE. ALL CONNECTIONS WERE ALSO CHECKED AND FOUND TO BE SECURE. THE REMAINDER OF THE TRANSPORT THE MONITOR STAYED IN "PADDLE" MODE, SO I WAS UNABLE TO SEE THE ACTUAL PATIENT RHYTHM APPROXIMATELY THREE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LP12 DEFRIBILLATOR/MONITOR MKJ MEDTRON PHYSIO CONTROL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other