BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORTARA INSTRUMENTS, INC. / QUINTON/QTEL TELEMETRY

    MDR report key: 6621496 · Received June 6, 2017

    Report

    Report Number
    MW5070242
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 5, 2017
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HR MONITORING INACCURACY: SYSTEM DOES NOT ALARM RELIABLY WHEN THRESHOLDS ARE MET OR EXCEEDED, RESULTING IN THE HIGHEST RISK OF CLINICAL IMPACT. PT WAS TRANSFERRED TO THE HOSPITAL 911 FOR CHEST PAIN. EXERCISE MONITOR STRIPS WERE REVIEWED AFTER THE PT WAS TRANSFERRED. MONITORING SYSTEM DID NOT ACCURATELY REGISTER THE PT'S CORRECT HR DURING EXERCISE. THEREFORE, THE ALARM SYSTEM DID NOT CORRECTLY ALERT STAFF THAT THE PT WAS EXCEEDING THE PRESCRIBED TARGET HR FOR EXERCISE. TOWER "CRASH" RESULTS IN PT DATA LOSS (EKG TRACING FOR THAT VISIT ENCOUNTER), RESULTING IN POTENTIAL BILLING COMPLIANCE ISSUE AS NO DOCUMENTATION EXISTS TO SUPPORT THE RENDERING OF SERVICE. PT F/U: MEDICAL RECORD D/C SUMMARY INDICATES FINAL DIAGNOSIS OF UNSTABLE ANGINA, CAD. PT UNDERWENT SUCCESSFUL PCI OF THE DISTAL L ANTERIOR DESCENDING CORONARY ARTERY ON (B)(6). PT DC IN STABLE CONDITION (B)(6) 2017. TROPONIN (-) X 3. FROM MEDICAL RECORD REVIEW, NO PT HARM RESULTED FROM POTENTIAL EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397824 MORTARA INSTRUMENTS, INC. / QUINTON/QTEL TELEMETRY QTEL DSI MORTARA INSTRUMENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization