BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2070487 · Received March 29, 2011

    Report

    Report Number
    9610816-2011-00162
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Report Date
    March 19, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DESCRIPTION NOTES THAT THE PT MONITOR WAS REPORTING A PT SPO2 READING OF 100%. THE PT'S BLOOD GAS SPO2 ANALYSIS WAS FOUND TO BE AT 77%. RISK ANALYSIS - PT HARM IS POSSIBLE SHOULD THE SPO2 VALUE BE FALSELY ELEVATED DURING THE MONITORING OF SPO2. TREATMENT MAY BE DELAYED AS THE USER IS UNAWARE OF THIS FALSE POSITIVE READING. PHILIPS HAS RECEIVED REPORTS WHERE INACCURATELY HIGH SPO2 READINGS HAVE LED TO FAILURE TO ALARM WHEN PTS HAVE DESATURATED. SINCE THIS MEASUREMENT AND ALARM IS INDICATIVE OF NEED FOR EMERGENT CARE, THIS DELAY OR LACK OF ALARM HAS RESULTED IN DELAY IN PROVIDING EMERGENT CARE. ROOT CAUSE - UNK. THE CITED PT MONITOR WAS NOT REMOVED FROM PT USE AND SEQUESTERED. THE PT MONITOR COULD NOT BE EVALUATED UPON A TECHNICAL ENGINEERING SUPPORT VISIT AS THIS MONITOR WAS BEING USED WITH A PT. THE CUSTOMER STATES THAT THE PT MONITOR IS OPERATING WITH NO FURTHER ISSUES IDENTIFIED. A BLOOD GAS SPO2 MEASUREMENT COMPARISON TO THE PT MONITOR SPO2 MEASUREMENT WAS PERFORMED. THE BLOOD GAS SPO2 MEASUREMENT RESULTS WERE IDENTICAL TO THE PT MONITOR. THE SPO2 SENSOR USED DURING THE REPORTED INCIDENT WAS NOT MADE AVAILABLE FOR TECHNICAL INVESTIGATION. THE CUSTOMER IS USING OXIMAX DISPOSABLE SPO2 SENSORS. THE CITED MONITOR WAS RECENTLY INSTALLED AT THE CUSTOMER SITE. AN SPO2 ADDENDUM WAS FORWARDED TO THE CUSTOMER'S NURSE MANAGER BY THE MANUFACTURER'S (B)(4). THIS ADDENDUM OFFERS SUGGESTIONS FOR OPTIMAL SPO2 MONITORING. THERE HAS BEEN NO FURTHER COMMUNICATION RECEIVED FROM THE CUSTOMER SITE REGARDING ANY SPO2 MEASUREMENT INACCURACIES. NO FURTHER ACTIONS HAVE BEEN IDENTIFIED FOR THE MANUFACTURE. BOTH THE DEVICE IFU (INSTRUCTIONS FOR USE) AND SPO2 ADDENDUM ADEQUATELY DESCRIBE USE CONDITIONS THAT CAN CAUSE FALSE SPO2 READINGS. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE PT MONITOR REPORTED AN INACCURATE SPO2 LEVEL. 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