BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR SHIELDS

    MDR report key: 111926 · Received June 4, 1997

    Report

    Report Number
    MW1011392
    Event Type
    Malfunction
    Date Received
    June 4, 1997
    Date of Event
    May 31, 1997
    Report Date
    June 4, 1997
    Manufacturer
    AIR SHIELDS, INC.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRETERM INFANT IN AIR SHIELDS ISOLETTE: INFANT CAUGHT BY NURSE AS IT FELL OUT OF ISOLETTE ARM PORTHOLE. INFANT WAS APPROX. 12" FROM FLOOR WHEN CAUGHT BY NURSE. WHITE PLASTIC DOOR CLOSURE CLASP WAS FOUND TO BE FAULTY. DID NOT SECURE TIGHTLY. VERY LIGHT PRESSURE WAS ENOUGH TO SPRING OPEN PORTHOLE DOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SHIELDS INFANT WARMER FMT AIR SHIELDS, INC. C100/200-2 SERIES 2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DAY