BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESUSCITATION MODULE

    MDR report key: 100283 · Received June 12, 1997

    Report

    Report Number
    2510954-1997-00005
    Event Type
    Malfunction
    Date Received
    June 12, 1997
    Date of Event
    May 20, 1997
    Report Date
    June 12, 1997
    Manufacturer
    AIR SHIELDS, INC.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED METAL PARTICLES WERE BEING DISCHARGED FROM THE OXYGEN OUTLET OF THE AIR-SHIELDS RESUSCITATION MODULE. THERE WAS NO PT INVOLVED. THE AIR SHIELDS RESUSCITATION MODULE IS AN ACCESSORY THAT MOUNTS ON THE POST OF THE INFANT INTENSIVE CARE SYSTEM FAMILY OF RADIANT WARMERS. THE MODULE PROVIDES THE "PLUMBING" TO CHANNEL AIR, OXYGEN, AND VACUUM FROM THE GAS SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUSCITATION MODULE GAS DELIVERY DEVICE FMT AIR SHIELDS, INC. RM78 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA