BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESUSCITAIRE

    MDR report key: 934515 · Received October 25, 2007

    Report

    Report Number
    2510954-2007-00003
    Event Type
    Other
    Date Received
    October 25, 2007
    Date of Event
    September 26, 2007
    Report Date
    October 23, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, (PNC)
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PROBLEM COULD NOT BE DUPLICATED; THEREFORE, NO MALFUNCTION OF THE DEVICE COULD BE CONFIRMED, AND NO CONCLUSION COULD BE DRAWN. AFTER RECEIPT OF THE REPORT, A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE REPORTED FAILURE. THE USER FACILITY IN CONJUNCTION WITH A DRAEGER MEDICAL FIELD SERVICE ENGINEER CONDUCTED A JOINT EVAL OF THE DEVICE. THE DEVICE WAS FOUND TO BE OPERATING ACCORDING TO SPECIFICATIONS, WHICH INCLUDED THE OPERATION OF THE BABY TEMPERATURE AND CHECK PT ALARMS. THE RESUSCITAIRE IS DESIGNED TO MEET THE APPLICABLE REQUIREMENTS OF IEC, "MEDICAL ELECTRICAL EQUIPMENT, PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFANT RADIANT WARMERS." THE ALARM CIRCUITRY IS INDEPENDENT FROM THE CONTROL CIRCUITRY. THE RESUSCITAIRE WOULD PRODUCE AUDIBLE AND VISUAL ALARMS IF THE SENSED TEMPERATURE DEVIATES FROM THE SET TEMPERATURE +/-1.0 C IN BABY MODE, AD WILL GENERATE A VISUAL AND AUDIBLE CHECK PT ALARM IN MANUAL MODE AFTER 10 MINUTES OF OPERATION AT 30 SECONDS INTERVALS, AND A CONTINUOUS ALARM AFTER 15 MINUTES OF OPERATION WHILE ALSO DISABLING THE HEATER. PROPER OPERATION WAS CONFIRMED DURING THE ABOVE EVAL. IN ADDITION TO THE ABOVE EVAL, WE HAVE ATTEMPTED TO OBTAIN MORE INFO RELATED TO THE REPORTED INCIDENT AND SUPPLIED A "RADIANT WARMER HEATING INVESTIGATION CHECKLIST" WHICH I HAVE SUPPLIED FOR REFERENCE. TO DATE, WE HAVE NOT RECEIVED ANY OF THE ADD'L INFO REQUESTED IN THE AFOREMENTIONED CHECKLIST. IF WE RECEIVE ANY ADD'L PERTINENT INFO RELATING TO THIS EVENT, WE WILL ISSUE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    "BABY PLACED ONTO THE RADIANT WARMER AT 1:30, TEMPERATURE PROBE IN PLACE. TEMP SET AT 36.5 C. WARMER NOTED TO BE WORKING WHEN TEMPERATURE CONTROL WAS SET TO PT MODE. AT 2:00, I WENT TO TAKE VITAL SIGNS, BABY WAS NOTED TO BE REDDENED ON FACE, ABDOMEN, AND LEGS (WHAT WAS IN DIRECT EXPOSURE OF RADIANT WARMER). WARMER AREA NOTED TO BE MUCH MORE WARMER THAN USUAL. BABY'S TEMPERATURE WAS 102.9 AUXILIARY. BABY MOVED TO ANOTHER RADIANT WARMER." CONTACT WAS MADE WITH DOCTOR REGARDING BABY'S SKIN CONDITION, BABY BATHED AND COOL WASHCLOTH, THEN PLACED OVER ABDOMEN. BY 4: 00, REDNESS WAS COMPLETELY RESOLVED. WORK ORDER WAS MADE, RADIANT WARMER REMOVED FROM OB DEPARTMENT BY SECURITY OFFICER. "IF WARMER LEFT IN "MANUAL MODE" BY ACCIDENT, THERE SHOULD HAVE BEEN ALARMS TO CHECK PT AFTER A FEW MINUTES AT REGULAR INTERVALS. THERE WERE NO ALARMS WITH THIS PARTICULAR INCIDENT. THERE WAS NO INDICATION OF A PROBLEM WITH THE PT'S TEMPERATURE ON THE WARMER, THE PT'S TEMPERATURE WAS READING 36. 5."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR