BEUDAMED
    FDA Adverse Event Other Summary report: N

    MP50 INTELLIVUE PATIENT MONITOR

    MDR report key: 2439648 · Received January 19, 2012

    Report

    Report Number
    9610816-2012-00027
    Event Type
    Other
    Date Received
    January 19, 2012
    Report Date
    January 16, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT A PT DEATH OCCURRED WHILE BEING MONITORED BY A PHILIPS DEVICE. THE USER INDICATES THAT THERE IS NO KNOWN CORRELATION BETWEEN THE DEATH AND OPERATING OF THE MONITOR. HOWEVER, THE CLINICIAN REPORTS THAT THE CITED MONITOR APPEARS TO SILENCE ITSELF IN RESPONSE TO HIGH PRIORITY ALARM CONDITION. PT HARM IS POSSIBLE SHOULD THE USER BE UNAWARE OF A CHANGE IN THE PT'S STATUS WHEN THE PT'S VITAL SIGNS HAVE EXCEEDED THE MONITOR'S PRECONFIGURED PARAMETERS. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L 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 A PT DEATH OCCURRED WHILE BEING MONITORED BY A PHILIPS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP50 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8004A

    Patients

    Seq Age Sex Outcome Treatment
    1