BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 1890765 · Received November 1, 2010

    Report

    Report Number
    9610816-2010-00568
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Report Date
    September 30, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THERE WAS A FAILURE TO ALARM. NO PATIENT HARM WAS REPORTED. THE CUSTOMER REPORTED THAT THE ALARM DID NOT SOUND WHEN THE SPO2 LEVEL WENT BELOW THE ALARM LIMITS, BUT THEY DID NOT REPORT HOW LONG THE CONDITION LASTED OR WHAT WAS THE ALARM DELAY SETTING OR ALARM AVERAGING SETTING. THE AVAILABLE INFORMATION IS THEREFORE NOT SUFFICIENT TO DETERMINE WHETHER THERE WAS ANY MALFUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 THERE WAS A FAILURE TO ALARM. NO PATIENT 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