BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2051376 · Received April 4, 2011

    Report

    Report Number
    9610816-2011-00179
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Report Date
    March 29, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A NURSE WHO DOES NOT HAVE PERMISSIONS TO TURN OFF ALARMS WAS STILL ABLE TO TURN OFF THE ALARMS. THE CUSTOMER WAS CONCERNED THAT THE MONITOR MAY NOT ALARM AS EXPECTED. NO PT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO CONCERNING THIS EVENT 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 DID NOT ALARM AS EXPECTED. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MHX PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1