BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    MDR report key: 2215952 · Received August 9, 2011

    Report

    Report Number
    9610816-2011-00449
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Report Date
    July 26, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE MONITOR REVERTED AUTOMATICALLY TO THE NEONATAL PROFILE WHEN MONITORING AN ADULT PT WITHOUT USER INTERACTION. NO PT HARM WAS REPORTED. THE NEONATAL PROFILE WAS LABELED AS "---", SO MAY HAVE BEEN DIFFICULT TO RECOGNIZE THAT THE PROFILE HAD CHANGED. WITH THE AVAILABLE INFO, IT IS CONSIDERED THAT THE NEONATAL DEFAULTS ARE NOT SUITABLE FOR THE ADULT PT CATEGORY, A CHANGE TO A NEONATAL DEFAULT PROFILE COULD POSE A DELAY IN TREATMENT AND A HEALTH RISK, AS, FOR EXAMPLE, THE HEART RATE ALARMS OR SPO2 ALARM LIMITS AND DELAYS COULD BE INAPPROPRIATE FOR AN ADULT PT. FOR EXAMPLE, AN ADULT WITH A RAISED HEART RATE WOULD NOT NECESSARILY TRIGGER AN UPPER LIMIT HEART RATE ALARM IF THE SETTINGS ARE THOSE FOR A NEONATAL PT. THEREFORE, IN THE ABSENCE OF FURTHER INFO, WE WILL REPORT THIS ISSUE IN ABUNDANT CAUTION. 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 MONITOR REVERTED AUTOMATICALLY TO THE NEONATAL PROFILE WHEN MONITORING AN ADULT PT WITHOUT USER INTERACTION. NO PT HARM WAS REPORTED.

    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