BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR SHIELDS RESUSCITAIRE

    MDR report key: 271513 · Received March 28, 2000

    Report

    Report Number
    271513
    Event Type
    Injury
    Date Received
    March 28, 2000
    Date of Event
    March 16, 2000
    Report Date
    March 28, 2000
    Manufacturer
    AIR SHIELDS, INC.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AIRSHIELDS INFANT WARMER MODEL WBR81-1 MALFUNCTIONED WHILE IN USE WITH INFANT. UNABLE TO CONTROL HEAT OUTPUT - ALL OR NOTHING. EQUIPMENT READ "ERROR 17".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SHIELDS RESUSCITAIRE INFANT WARMER FMT AIR SHIELDS, INC. BRW 81-1/WBR81-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Required Intervention