BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2121195 · Received May 4, 2011

    Report

    Report Number
    9610816-2011-00231
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    April 6, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE REPORTED DESCRIPTION OF THIS COMPLAINT NOTES THAT A PT MONITOR WITHIN A CAREGROUP APPLICATION DID NOT RECEIVE A TRANSFERRED ALARM FROM THE MONITOR WITHIN THE CONFIGURED CAREGROUP. NO PT HARM WAS REPORTED. THE SVC EVENT RECORD INDICATES THAT THE DEVICE WAS TESTED AND OPERATES AS EXPECTED/INTENDED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL 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 REPORTED DESCRIPTION OF THIS COMPLAINT NOTES THAT A PT MONITOR WITHIN A CAREGROUP APPLICATION DID NOT RECEIVE A TRANSFERRED ALARM FROM THE MONITOR WITHIN THE CONFIGURED CAREGROUP. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP70 INTELLIVUE PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1