BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESUSCITAIRE RW82/WBR82

    MDR report key: 996580 · Received February 8, 2008

    Report

    Report Number
    2510954-2008-00001
    Event Type
    Injury
    Date Received
    February 8, 2008
    Date of Event
    January 3, 2008
    Report Date
    February 8, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (PNC)
    Product Code
    FMT
    PMA / PMN Number
    K003335
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS NOT ALLOWED DRAEGER TO INSPECT THE DEVICE. IT WAS REPORTED THAT THE UNIT WAS BEING USED IN THE MANUAL HEATING MODE. IN THIS MODE, THE USER SHOULD CONSTANTLY OBSERVE THE INFANT, AND MONITOR THE INFANT TEMPERATURE TO AVOID OVER HEATING OR UNDER HEATING. THE DEVICE IS DESIGNED SO THAT WHEN IN MANUAL MODE IF THE WARMER IS IN OPERATION FOR LONGER THAN 10 MINS, THE CHECK PT INDICATOR ILLUMINATES AND THE ALARM SOUNDS. THE INDICATOR REMAINS ILLUMINATED, AND THE ALARM CONTINUES TO SOUND EVERY 30 SECONDS FOR 5 MINS OR UNTIL THE USER ACKNOWLEDGES THE ALARM. IF THE ALARM HAS NOT BEEN ACKNOWLEDGED FOR A TOTAL OF 15 MINS, THE HEATER WILL SHUT OFF AND A THREE LEVEL ALARM SOUNDS CONTINUOUSLY. THE USER MUST ACKNOWLEDGE THIS ALARM TO RESTART THE HEATER OUTPUT. THE INVESTIGATION HAS NOT DETERMINED ANY PRODUCT MALFUNCTION. THE REPORTED PT INJURY MAY POTENTIALLY BE DUE TO USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: A NINE MONTH OLD BABY WAS PLACED IN A RW82 FOR ABOUT 30 MINS USING THE MANUAL MODE. DURING THIS TIME, THE BABY WAS SLIGHTLY BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESUSCITAIRE RW82/WBR82 INFANT RADIANT WARMER FMT DRAEGER MEDICAL SYSTEMS, INC. (PNC) RW82

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Required Intervention