BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP2

    MDR report key: 1812766 · Received August 17, 2010

    Report

    Report Number
    9610816-2010-00312
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Report Date
    August 3, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K040357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THIS INTELLIVUE X2 MEASUREMENT SERVER HAD GENERATED A VISIBLE "SPEAKER MALFUNC." INOP MESSAGE AND THAT THE SPEAKER ASSY HAD FAILED TO GENERATE ANY SOUND AT ALL. THE CUSTOMER FURTHERMORE REPORTED THAT ALARM LIGHTS TURN ON AND THEY CAN SEE ALARMS BUT THERE IS NO SOUND. AT THIS POINT IN TIME, IT REMAINS UNKNOWN IF THIS "ALARM" REPRESENTS THE DISPLAYED INOP MESSAGE, OR IF IN FACT A PARAMETER ALARM WAS GENERATED. AS THE CUSTOMER HAS APPARENTLY RECOGNIZED THE SITUATION/ALARM/SPEAKER FAILURE, AND AS NO PATIENT ADVERSE EVENT/ADVERSE PATIENT IMPACT WAS REPORTED TO HAVE RESULTED FROM THIS ISSUE, IT IS CONSIDERED THAT THE ISSUE WAS IMMEDIATELY OBVIOUS TO THE USER. GENERALLY, PATIENT ALARMS & TECHNICAL INOPS WILL CONTINUE TO BE ANNUNCIATED AT THE CENTRAL STATION (IF NETWORKED). IN AN ABUNDANCE OF CAUTION, WE WILL REPORT LOSS OF AUDIO EVEN THOUGH A VISUAL WARNING IS PROVIDED AND PRODUCT LABELING DESCRIBES PERSONAL SURVEILLANCE. THE INTENTION ON MONITORING WOULD BE IN CLOSE PERSONAL OBSERVATION AS SPECIFIED IN THE PRODUCT LABELING. THIS WOULD ALERT THE USER TO A POSSIBLE DEVICE ISSUE TO TROUBLESHOOT THE DEVICE OR IMPLEMENT ALTERNATIVE MONITORING PER HOSPITAL PROTOCOL, AND/OR TO TROUBLESHOOT THE MONITOR. 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 THIS INTELLIVUE X2 MEASUREMENT SERVER HAD GENERATED A VISIBLE "SPEAKER MALFUNC." INOP MESSAGE AND THAT THE SPEAKER ASSY HAD FAILED TO GENERATE ANY SOUND AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MP2 MHX PHILIPS MEDICAL SYSTEMS M8102A

    Patients

    Seq Age Sex Outcome Treatment
    1