BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTA XL

    MDR report key: 897505 · Received August 14, 2007

    Report

    Report Number
    1220063-2007-00022
    Event Type
    Other
    Date Received
    August 14, 2007
    Date of Event
    May 13, 2007
    Report Date
    August 10, 2007
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT EVALUATED BY THE MANUFACTURER BUT WE DID RECEIVE THE ELECTRONIC DEVICE LOGS AND SCREEN SHOTS THAT DRAEGER MEDICAL ENGINEERING USED TO INVESTIGATE THE REPORTED INCIDENT. THE ALGORITHM USES THE PATIENT'S ESTIMATED HEART RATE FROM EKG AND/OR SPO2 TO DETERMINE ITS OPTIMAL INTERNAL FILTER TO REMOVE EXTRANEOUS SIGNALS. INSTANTANEOUS CHANGES IN HEART RATE (AS WHEN THE PROBE IS MOVED BETWEEN INDIVIDUALS WITHOUT RESETTING) OR CONNECTION OF 2 COMPETING HEART RATE SOURCES (AS WHEN EKG IS CONNECTED TO DIFFERENT INDIVIDUAL FROM SPO2) CAN CAUSE THE WRONG FILTER TO BE SELECTED. THE ALGORITHM IS NOT DESIGNED TO SUPPORT THESE NON-CLINICAL USE MODELS. THE ONLY KNOWN CAUSE OF WRONG SATURATION OR PULSE RATE WITH VF6.6 ARISES FROM THE NON-CLINICAL INSTANTANEOUS MOVEMENT OF THE PROBE FROM ONE INDIVIDUAL TO ANOTHER, OR FROM CONNECTING 2 INDIVIDUALS SIMULTANEOUSLY (EKG AND SPO2). IN NORMAL CLINICAL USE, PATIENTS SHOULD BE DISCHARGED BEFORE ANOTHER IS ADMITTED, PREVENTING THIS TISSUE FROM OCCURRING. IF A 'SPOT CHECK' OF ANOTHER INDIVIDUAL IS PERFORMED, THE SPO2 ALGORITHM SHOULD BE 'RESET' BY BRIEFLY DISCONNECTING THE SPO2 PROBE FROM THE INTERMEDIATE CABLE, OR DISCONNECT THE INTERMEDIATE CABLE FROM THE MULTIMED. LIKE ALL SPO2 ALGORITHMS, THE DRAEGER ALGORITHM INCORPORATES A 'HOLD PERIOD' OF UP-TO 30 SECONDS WHEN PRESENTED WITH NOISY OR ARTIFACTUAL DATA. THIS HOLD PERIOD IS COMPLIANT WITH THE STANDARD FOR SPO2 MONITORING (ISO-9919), AND IS AN IMPORTANT PART OF THE FALSE ALARM REDUCTION MECHANISM. DRAEGER MEDICAL SYSTEMS, INC. IS NOT PLANNING ANY CORRECTIVE ACTION AT THIS TIME HOWEVER, WE WILL CONTINUE TO MONITOR FOR THE REPORTED CONDITION AS WELL A CONTINUALLY WORKING TO IMPROVE THE PERFORMANCE OF OUR SPO2 ALGORITHM.

    Description of Event or Problem · 1

    DRAEGER MEDICAL SYSTEMS, INC. HAD RECEIVED INFORMATION FROM OUR LOCAL OFFICE THAT CUSTOMER REPORTED THAT WHILE MONITORING A PATIENT, (BABY) USING OUR DELTA XL PATIENT MONITOR FOR SPO2 SATURATION LEVELS A VALUE OF 98% WAS DISPLAYED EVEN THOUGH THE BABY'S SKIN COLOR WAS PALE GREY AND MARBLED. WITH AN ADDITIONAL PULSOXY MONITORING OF THE PATIENT A VALUE OF 39% WAS MEASURED. ACCORDING TO THE ATTENDING NURSE, THIS PROBLEM OCCURS MAINLY WITH NEONATES OF A WEIGHT BELOW 700G AND/OR TO WEEK 25 OF GESTATION. THE CUSTOMER REPORTED THAT THE CONDITION OF THE BABY HAD IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA XL DELTA XL PATIENT MONITOR MHX DRAEGER MEDICAL SYSTEMS, INC. MS13474 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention