BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR SHIELDS

    MDR report key: 255042 · Received December 16, 1999

    Report

    Report Number
    255042
    Event Type
    Other
    Date Received
    December 16, 1999
    Date of Event
    June 9, 1999
    Report Date
    June 14, 1999
    Manufacturer
    HILL-ROM AIR-SHIELDS
    Product Code
    FMZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    A 3 WK OLD, 3.5 LB INFANT WITH IUGR (INTRAUTERINE GROWTH RETARDATION) FELL FROM LEFT PORTHOLE OF ISOLETTE AND SUFFERED A SKULL FRACTURE AND EXTRADURAL HEMATOMA. DOORS OF PORTHOLES ON THIS ISOLETTE DO NOT LOCK UNLESS PUSHED VERY FORCEFULLY AND CLICK CLOSED; WITH LESSER FORCE VERY LITTLE PRESSURE REQUIRED TO OPEN DOOR FROM INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SHIELDS ISOLETTE FMZ HILL-ROM AIR-SHIELDS C100/200-2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DAY Other