BEUDAMED
    FDA Adverse Event Other Summary report: N

    OHMEDA MEDICAL GIRAFFE OMNIBED

    MDR report key: 326478 · Received April 11, 2001

    Report

    Report Number
    1121732-2001-00002
    Event Type
    Other
    Date Received
    April 11, 2001
    Date of Event
    March 11, 2001
    Report Date
    March 12, 2001
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY AN INFANT WAS NOTED BY CLINICAL STAFF TO HAVE A POSSIBLE "ARRHYTHMIA" ACCORDING TO AN EKG MONITOR. THE DAY NURSE CHANGED THE EKG LEADS AND MONITOR & THE "ARRHYTHMIA" PATTERN DISAPPEARED. DURING THE EVENING SHIFT, THE ABNORMAL PATTERN REAPPEARED, AT WHICH TIME THEY CHANGED THE EKG LEADS, MONITOR, AND ELECTRICAL OUTLET INTO WHICH THE BED WAS PLUGGED, AS WELL AS THE PHYSICAL LOCATION OF THE BED, YET THE PROBLEM REMAINED. THE ATTENDING NEONATOLOGIST INTERPRETED THE PATTERN ON THE MONITOR AND THE EKG LEAD AS ATRIAL FLUTTER/FIBRILLATION AND ORDERED 50 MCG ADENOSINE IV WHICH WAS GIVEN AS ORDERED. UPON ADVICE OF THE CARDIOLOGIST THE BED WAS TURNED OFF (IT HAD BEEN IN AIR CONTROL INCUBATOR MODE) & THE ABNORMAL PATTERN DISAPPEARED. NO COMPROMISE IN VITAL SIGNS WERE EVER NOTED BY CLINICAL STAFF. THE BABY WAS REMOVED FROM THE DEVICE, AND AN EKG SHOWED NO EFFECTS OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16411 OHMEDA MEDICAL GIRAFFE OMNIBED INFANT INCUBATOR FMT OHMEDA MEDICAL OMNIBED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DAY Other HEWLET PACKARD MONITORING SYSTEM.