BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIVIEW WORKSTATION

    MDR report key: 865954 · Received June 8, 2007

    Report

    Report Number
    1220063-2007-00009
    Event Type
    Other
    Date Received
    June 8, 2007
    Date of Event
    May 10, 2007
    Report Date
    June 12, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND SENSOR WAS NOT MADE AVAILABLE TO DRAEGER MEDICAL SYSTEMS FOR EVALUATION. WE HAD REQUESTED THAT THE CITED SP02 SENSOR, PATIENT MONITOR AND SPECIFIC DETAILS AS TO THE PROTOCOL FOR SP02 MEASUREMENT/PATIENT SURVEILLANCE USED AT THE CUSTOMER SITE BE PROVIDED TO DRAEGER MEDICAL SYSTEMS, INC. WE RECEIVED A COMMUNICATION FORM OUR LOCAL OFFICE THAT THE CUSTOMER IS UNABLE TO SUPPLY US WITH REQUESTED INFORMATION NEEDED TO INVESTIGATE THE REPORTED INCIDENT. THE CUSTOMER HAS FURTHER REPORTED THAT THEY ARE HAPPY WITH THE PERFORMANCE OR OUR SP02 MONITORING SYSTEM AND THAT NO OTHER REPORTED INCIDENTS OF THIS TYPE HAVE OCCURRED. BASED ON THE INFORMATION RECEIVED FROM OUR LOCAL OFFICE VIA COMMUNICATIONS RECEIVED FROM THE CUSTOMER, WE ARE UNABLE TO PERFORM AN EFFECTIVE INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. WE DID, HOWEVER, REQUEST THAT OUR LOCAL OFFICE COMMUNICATE TO THE CUSTOMER TO BE AWARE OF OUR PRECAUTIONS LISTED IN OUR INSTRUCTIONS FOR USE WITH REGARD TO SP02 MONITORING THAT INDICATE "CHECK THE SENSOR AT LEAST EVERY FOUR HOURS. MOVE THE SENSOR IF THERE IS ANY SIGN OF SKIN IRRITATION OR IMPAIRED CIRCULATION".

    Description of Event or Problem · 1

    A CUSTOMER HAS REPORTED THAT AFTER USING A DRAEGER MEDICAL SYSTEMS DELTA PATIENT MONITOR AND SUPPLIED SP02 SENSOR ON AN INFANT, IT WAS NOTICED THAT THE SKIN WAS SLIGHTLY BURNED (INTACT BUT RED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIVIEW WORKSTATION OXYGEN SATURATION PROBE DSI DRAEGER MEDICAL SYSTEMS, INC. 7496974 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other