BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR SHIELDS RADIANT INFANT WARMER

    MDR report key: 9311 · Received March 22, 1994

    Report

    Report Number
    9311
    Event Type
    Injury
    Date Received
    March 22, 1994
    Date of Event
    December 17, 1993
    Report Date
    March 22, 1994
    Manufacturer
    UNKNOWN
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THIS INCIDENT INVOLVED AN AIR SHIELDS RADIANT INFANT WARMER, WHEREIN PART OF THE CERAMIC HEATER FELL INTO THE WARMER BED BURNING THE BABY'S LEG. THIS DID NOT RESULT IN ANY DISABILITY. THE DATE OF THE INCIDENT WAS 12/17/93. THIS INCIDENT HAS BEEN REPORTED TO MANUFACTURER.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR SHIELDS RADIANT INFANT WARMER FMT UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention