BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE MULTI MEASUREMENT SEVER X2

    MDR report key: 2213020 · Received August 9, 2011

    Report

    Report Number
    9610816-2011-00470
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    August 3, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K071426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE APNEA ALARM LIMITS ON THE X2 MONITORS APPEARED TO HAVE CHANGED SPONTANEOUSLY, LEADING TO A PT INCIDENT. BASED ON THE AVAILABLE INFO, A USER RELATED ISSUE MAY BE RELATED AS THE DEVICES HAVE BEEN CONFIGURED SO THAT THE HOST MONITOR OVERRIDES THE X2 SETTINGS. HOWEVER, SINCE THE CONTRIBUTION OF THE DEVICE IS UNK THIS PR IS CONSIDERED REPORTABLE. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL CONCLUSION WILL BE MADE ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE APNEA ALARM LIMITS ON THE X2 MONITOR APPEARED TO HAVE CHANGED SPONTANEOUSLY, LEADING TO A PT INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1