BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECG MONITOR

    MDR report key: 29773 · Received January 11, 1996

    Report

    Report Number
    29773
    Event Type
    Other
    Date Received
    January 11, 1996
    Date of Event
    November 20, 1995
    Report Date
    December 11, 1995
    Manufacturer
    HEWLETT PACKARD
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 74 YR OLD IN E.R. WITH CHEST PAIN. INITIALLY GIVEN SL NTG WITH RELIEF. WAS BEING MONITORED ON CARDIAC MONITOR. PT WENT INTO V-FIB AND ARRESTED. CARDIAC MONITOR DID NOT ALARM BUT SITUATION DETECTED BY STAFF IMMEDIATELY. THE PT WAS SUCCESSFULLY RESUSCITATED/CARDIOVERTED. DIAGNOSED WITH AN MI. HOSPITALIZED FOR 7 DAYS AND DISCHARGED HOME. BIOENGINEERING INSPECTION OF MONITOR DETERMINED VOLUME OF ALARM ON LOW SETTING AND ALARM IN OFF POSITION AS A RESULT OF A POWER FLUCTUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECG MONITOR CARDIAC MONITOR DRT HEWLETT PACKARD

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other