BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 1935096 · Received December 6, 2010

    Report

    Report Number
    9610816-2010-00781
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Report Date
    November 18, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE STOPPED FUNCTIONING DURING MONITORING AND THE STAFF COULD NOT RESTORE SERVICE. THE CUSTOMER TROUBLESHOT THE ISSUE BY EXCHANGING THE USED, NON-IDENTIFIED SENSOR AND SENSOR CABLE WITH DIFFERENT ONES, HOWEVER, WAS NOT ABLE TO RESTORE OPERATION OF SPO2. ONCE THE QUESTIONABLE X2 WAS EXCHANGED WITH A DIFFERENT ONE (BUT WITH ORIGINAL SPO2 SENSOR AND CABLE), SPO2 OPERATION COULD BE RESTORED. NO ADDITIONAL INFO ABOUT APPEARANCE OR CONTEXT OF FAILURE WAS PROVIDED. ALSO USED SPO2 ACCESSORIES AT TIME OF LOSS REMAIN UNK. UPON TESTING THE QUESTIONABLE X2 ON HERSELF POST INCIDENT, THE HOSP BIOMED VERIFIED THAT SPO2 WAS WORKING PROPERLY. THE CUSTOMER INDICATED THAT THIS BEHAVIOR HAD BEEN OBSERVED BEFORE. NO DEATH, SERIOUS INJURY OR ADVERSE EVENT OCCURRED OR WAS REPORTED AS A RESULT OF SUCH AN ISSUE. BASED ON THE AVAILABLE INFO, THE REPORT FROM THE CUSTOMER INDICATES THAT SPO2 PARAMETER FUNCTION WAS LOST FOR AN UNDETERMINED TIME PERIOD. THE LIMITED AVAILABLE INFO ABOUT THE 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 OF 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. USER REFERENCE GUIDES DESCRIBE PERSONAL SURVEILLANCE, WHICH WOULD ALLOW THE USER TO IMPLEMENT ALTERNATIVE METHODS OF MONITORING PER HOSP PROTOCOL, AND/OR TROUBLESHOOT THE MONITOR. 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 THE DEVICE STOPPED FUNCTIONING DURING MONITORING AND THE STAFF COULD NOT RESTORE SERVICE.

    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