BEUDAMED
    FDA Adverse Event Other Summary report: N

    OHMEDA CARE PLUS INCUBATOR

    MDR report key: 411068 · Received August 16, 2002

    Report

    Report Number
    1121732-2002-00002
    Event Type
    Other
    Date Received
    August 16, 2002
    Date of Event
    July 13, 2002
    Report Date
    August 13, 2002
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A FULL TERM, ACTIVE PT FELL FROM THE INCUBATOR AFTER THE DOOR HAD BEEN LEFT OPEN BY A CAREGIVER. THERE HAD BEEN SEVERAL CLINICIANS WORKING WITH THE PT AND APPARENTLY NO-ONE CLOSED THE INCUBATOR DOOR WHEN THEY WERE FINISHED. CAT SCAN WAS CONDUCTED ON THE PT TO DETERMINE WHETHER THERE WERE ANY RESULTING INJURIES, AND EVERYTHING WAS FOUND TO BE NORMAL - THERE WERE NO INJURIES OTHER THAN BRUISING ON PT'S KNEES. BOTH HOSP BIOMEDICAL PERSONNEL AND OHMEDA MEDICAL SERVICE REPRESENTATIVES THOROUGHLY EVALUATED THE EQUIPMENT AND FOUND THE DOOR LATCHES TO BE IN GOOD WORKING ORDER, AND THE UNIT WAS OPERATING AS INTENDED. THE HOSP IS CONSIDERING THIS AN OPERATOR ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA CARE PLUS INCUBATOR INFANT INCUBATOR FMT OHMEDA MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other