BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 161120 · Received March 31, 1998

    Report

    Report Number
    3015876-1998-00157
    Event Type
    Malfunction
    Date Received
    March 31, 1998
    Date of Event
    March 1, 1998
    Report Date
    March 31, 1998
    Manufacturer
    PHYSIO-CONTROL CORP
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EMERGENCY DEPARTMENT PERSONNEL RESPONDED TO A PERSON DESCRIBED AS IN BRADYCARDIA. THE PT WAS CONNECTED TO THE DEVICE AS A PREVENTATIVE MEASURE. ACCORDING TO THE REPORTER, THE OPERATOR COULD NOT ADJUST THE PACING CURRENT ABOVE 0 MA. A BACKUP EXTERNAL PACEMAKER WAS CALLED FOR AND USED. NO ADVERSE AFFECTS TO THE PT WERE REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER EXTERNAL DC DEFIBRILLATOR/CARDIAC MONITOR/TRANSCUTANEOUS PAC LDD PHYSIO-CONTROL CORP 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN