BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP30 INTELLIVUE PATIENT MONITOR

    MDR report key: 2082750 · Received April 28, 2011

    Report

    Report Number
    9610816-2011-00222
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    April 7, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE ALARM SILENCE KEY IS ACTIVATING INDEPENDENTLY OF THE USER. NO PATIENT HARM WAS REPORTED. BASED ON THE PRODUCT INFORMATION, SHOULD THIS OCCUR, IT IS POSSIBLE THAT A PATIENT ALARM WILL NOT BE HEARD BY THE USER. THE CUSTOMER REPORTED THAT THIS TOUCH SCREEN WAS PHYSICALLY DAMAGED AND THE INDICATOR FOR ALARM SILENCING WAS APPEARING INTERMITTENTLY EVEN THOUGH THERE WAS NO ALARM CONDITION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 ALARM SILENCE KEY IS ACTIVATING INDEPENDENTLY OF THE USER. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP30 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8002A

    Patients

    Seq Age Sex Outcome Treatment
    1