BEUDAMED
    FDA Adverse Event Death Summary report: N

    NDR

    MDR report key: 219788 · Received April 20, 1999

    Report

    Report Number
    219788
    Event Type
    Death
    Date Received
    April 20, 1999
    Date of Event
    April 6, 1999
    Report Date
    April 20, 1999
    Manufacturer
    NDR CORP.
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT ON MECHANICAL VENTILATION AND WITH TELEMETRY MONITORING. BOTH SYSTEMS HAVE REMOTE ALARM SYSTEMS AUDIBLE AT THE NURSES STATION. NURSE ALERTED OF LOW HEART RATE BY TELEMETRY ALARM. NURSE WENT TO PT'S ROOM DISCOVERING PT DISCONNECTED FROM VENTILATOR. THE ALARM ON THE VENTILATOR UNIT WAS FUNCTIONING PROPERLY AND AUDIBLE. ADVANCED CARDIAC LIFE SUPPORT PROTOCOL WAS INITIATED BUT WAS UNSUCCESSFUL AND THE PT EXPIRED. THE REMOTE VENTILATOR ALARM CABLE CONNECTING THE VENTILATOR TO THE CALL SYSTEM WAS FOUND TO BE DEFECTIVE WHICH MAY HAVE CAUSED A DELAY IN STAFF BEING ALERTED TO THE VENTILATOR ALARM. REMOTE ALARM CABLE FUNCTION CHECKS HAD BEEN ROUTINELY PERFORMED ON A WEEKLY BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDR VENTILATOR REMOTE ALARM CABLE MHX NDR CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death IVAC IV PUMP, VENTILATOR, FEEDING PUMP, TELEMETRY,| AIR MATTRESS.