BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 1865046 · Received October 5, 2010

    Report

    Report Number
    9610816-2010-00499
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Report Date
    September 14, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE SPO2 PARAMETER ON THE REPORTED X2 HAD FAILED TO OPERATE PROPERLY. PER THE CUSTOMER, "SPO2 (IS) DROPPING OUT." NO FURTHER INFO ABOUT CONTEXT OR APPEARANCE OF FAILURE MODE WAS PROVIDED. THERE WAS NO INDICATION THAT THIS ISSUE INVOLVED A PT INCIDENT OR THAT THE DEVICE FAILED TO GENERATE AN ADEQUATE INOP MESSAGE. THE REPORT FROM THE CUSTOMER INDICATES THAT THE SPO2 PARAMETER WAS LOST FOR AN UNDETERMINED TIME PERIOD. THE LIMITED AVAILABLE INFO ABOUT THE POTENTIAL TIME PERIOD OF LOST MONITORING AND ABOUT WHETHER OR NOT THERE WERE INOPS IS NOT SUFFICIENT TO SUPPORT THAT THERE WAS A HEALTH RISK. IN ABUNDANT CAUTION, WE WILL REPORT THIS FAILURE. PLEASE NOTE THAT THE INTENTION ON MONITORING WOULD BE IN CLOSE PERSONAL OBSERVATION AS SPECIFIED IN PRODUCT LABELING. IN THIS CASE, THE LACK OF A FUNCTIONAL SPO2 PARAMETER, OR THE LACK OF SPO2 PT DATA BEING DISPLAYED AT THE HOST MONITOR WOULD BE (AND WAS) OBVIOUS TO USERS DURING CLOSE OBSERVATION. PHILIPS USER REFERENCE GUIDES DESCRIBE PERSONAL SURVEILLANCE ALLOWING THE USER TO IMPLEMENT ALTERNATIVE METHODS OF MONITORING PER HOSPITAL PROTOCOL, AND/OR TO TROUBLESHOOT THE MONITOR. LABELING (INSTRUCTIONS FOR USE) FOR THIS DEVICE EXPLAINS HOW TO PROPERLY PERFORM SPO2 MEASUREMENTS, AS WELL AS POTENTIAL CONDITIONS THAT WOULD CAUSE OR CONTRIBUTE TO INACCURATE/ERRONEOUS SPO2 READINGS/RESULTS. SUCH CONDITIONS WOULD INCLUDE INCORRECT POSITIONING OF THE SENSOR (LOOSE SENSOR, COMPROMISED OPTICAL ALIGNMENT), ENVIRONMENTAL INTERFERENCES (HIGH LEVELS OF AMBIENT LIGHT OR STROBE LIGHTS OR FLASHING LIGHTS, ELECTROMAGNETIC INTERFERENCE, AND EXCESSIVE PT MOVEMENT AND VIBRATION) & PT CHARACTERISTICS, AMONGST OTHERS. ALSO HUMIDITY COULD CONTRIBUTE TO INACCURATE READINGS. IT REMAINS UNK IF SUCH A CONDITION WAS PRESENT AT THE TIME OF INCIDENT. PHILIPS MONITORS OFFER A NUMBER OF INDICATORS, SUCH AS MAINTENANCE WARNING, TECHNICAL ALERTS (INOPS), PLETH WAVEFORM AND THE PERFUSION INDEX, TO WARN THE USER OF SUCH CONDITIONS AND TO ALLOW THE USER TO ASSESS THE QUALITY OF THE SIGNAL AND MEASURED SPO2 AND PULSE RATE. FOR THE SAFE USE OF PULSE OXIMETRY, IT IS ESSENTIAL TO FOLLOW GOOD CLINICAL PRACTICES, E.G PROPER SENSOR APPLICATION AND PERIODICALLY CHECKING THE MEASUREMENT SITE. THE MOST RELIABLE METHOD OF PT MONITORING COMBINES CLOSE PERSONAL SURVEILLANCE WITH CORRECT OPERATION OF MONITORING EQUIPMENT. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR SPO2 PARAMETER ON THE REPORTED X2 HAD FAILED TO OPERATE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLLIVUE MULTI MEASUREMENT SERVER X2 MHX PHILIPS MEDICAL SYSTEMS M3002A

    Patients

    Seq Age Sex Outcome Treatment
    1