BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 1865055 · Received October 5, 2010

    Report

    Report Number
    9610816-2010-00544
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Report Date
    September 16, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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, THEY HAD "PROBLEMS WITH PULSE OX WHERE THE ENTIRE WAVEFORM DISAPPEARS" AND REQUESTED WHETHER IT IS NORMAL THAT SPO2 DISAPPEARS WHEN SPO2 SENSOR IS UNPLUGGED. NO FURTHER INFORMATION ABOUT CONTEXT OR APPEARANCE OF FAILURE MODE WAS PROVIDED (E.G. IF JUST WAVEFORM DISAPPEARED, BUT NUMERIC WAS STILL PRESENT). 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 PATIENT DATA BEING DISPLAYED AT THE HOST MONITOR WOULD BE (AND WAS) OBVIOUS TO USERS DURING CLOSE OBSERVATION, WHICH IS DOCUMENTED IN THE USER REFERENCE GUIDES. THIS WOULD ALLOW 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 PATIENT MOVEMENT AND VIBRATION) & PATIENT CHARACTERISTICS, AMONGST OTHERS. ALSO HUMIDITY COULD CONTRIBUTE TO INACCURATE READINGS. IT REMAINS UNKNOWN IF SUCH A CONDITION WAS PRESENT AT TIME OF INCIDENT. PHILIPS MONITORS OFFER A NUMBER OF INDICATORS, SUCH AS MAINTENANCE WARNINGS, 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 PATIENT MONITORING COMBINES CLOSE PERSONAL SURVEILLANCE WITH CORRECT OPERATION OF MONITORING EQUIPMENT. THERE WAS NO INDICATION THAT THIS ISSUE INVOLVED A PATIENT INCIDENT. THE REPORT FROM THE CUSTOMER INDICATES THAT THE SPO2 PARAMETER WAS LOST FOR AN UNDETERMINED TIME PERIOD. THE LIMITED AVAILABLE INFORMATION 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, PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 THE SPO2 PARAMETER ON THE REPORTED X2 HAD FAILED TO OPERATE PROPERLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1