BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUIK PACE EXTERNAL NON-INVASIVE PACEMAKER

    MDR report key: 10843 · Received January 6, 1994

    Report

    Report Number
    MW1000313
    Event Type
    Other
    Date Received
    January 6, 1994
    Date of Event
    December 17, 1993
    Report Date
    December 27, 1993
    Manufacturer
    PHYSIO-CONTROL CORP.
    Product Code
    DRO
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    EMERGENCY DEPT STAFF AT HOSP ATTEMPTED TO EXTERNALLY PACE A PT WITH PACEMAKER. THE UNIT WOULD NOT PACE BECAUSE IT ALARMED "LEADS OFF." EVEN THOUGH THE LEADS WERE ON THE PT. NEW ELECTRODES AND A NEW LEAD SET WERE TRIED WITHOUT POSITIVE RESULTS. ON TESTING IT WAS FOUND THAT THE UNIT WORKED PROPERLY ACCORDING TO THE "ECG LEADS OFF" TEST IN THE SVC PERFORMANCE VERFICIATION PROCEDURE. BUT THE ECG INPUT BOARD COULD NOT BE ADJUSTED TO ACHIEVE THE RESULTS DESCRIBED IN THE "ECG LEADS OFF THRESHOLDS" TEST AND TROUBLESHOOTING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIK PACE EXTERNAL NON-INVASIVE PACEMAKER DRO PHYSIO-CONTROL CORP. QUIK PACE

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other