BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHIO TRANSPORT INCUBATOR

    MDR report key: 174297 · Received June 26, 1998

    Report

    Report Number
    174297
    Event Type
    Malfunction
    Date Received
    June 26, 1998
    Date of Event
    April 28, 1998
    Report Date
    May 5, 1998
    Manufacturer
    OHIO MEDICAL PRODUCT OHMEDA CO.
    Product Code
    FPL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TRANSPORT INCUBATOR PLUGGED IN IN SPECIAL CARE NURSERY. NO BABIES IN THIS ROOM AT THIS TIME. STAFF MEMBER IN ROOM NOTED THICK, YELLOW SMOKE FROM AREA NEAR ISOLETTE. PLUG COOL TO TOUCH & TRANSPORT MOVED WITH HANDLES. TRANSFORMER MELTED. INFANTS MOVED FROM NURSERY IMMEDIATELY. 2 STAFF MEMBERS FROM LABOR & DELIVERY COMPLAINED OF SYMPTOMS. CHECKED BY OCCUPATIONAL HLTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHIO TRANSPORT INCUBATOR AIRVAC INCUBATOR FPL OHIO MEDICAL PRODUCT OHMEDA CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * OHIO MEDICAL PRODUCT-BATTERY PACK| MODEL #217-3813-910