BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESUSCITAIRE

    MDR report key: 1872732 · Received October 12, 2010

    Report

    Report Number
    2510954-2010-00009
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 13, 2010
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    FMT
    PMA / PMN Number
    K003335
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE STILL INVESTIGATING THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED AS SOON AS WE COMPLETE OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TRANSPORTED (POST ANESTHESIA) FROM THE OPERATING ROOM TO THE NURSERY. ONE NURSE WAS ON THE BASSINET END THE WARMER (USING THE PUSH/PULL HANDLE), THE OTHER NURSE WAS ASSISTING TO GUIDE THE WARMER ON THE POST END OF THE WARMER. THE WARMER POST TIPPED FORWARD AND THE NURSE ON THE BASSINET END CAUGHT THE INFANT. THE INFANT WAS IN THE WARMER APPROXIMATELY 10 TO 15 MINUTES BEFORE THE INCIDENT OCCURRED. NO INJURY WAS SUSTAINED BY THE INFANT OR ANY HOSPITAL STAFF MEMBERS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUSCITAIRE INFANT RADIANT WARMER FMT DRAGER MEDICAL SYSTEMS, INC. (PNC) RW82VHA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK