BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2220337 · Received July 27, 2011

    Report

    Report Number
    9610816-2011-00436
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 19, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE PATIENT WAS BEING MONITORED USING SPO2 PULSE OXIMETRY ONLY. THERE WAS NO ACTIVE ECG MONITORING. THE PATIENT'S SPO2 ALARM LIMIT WAS EXCEEDED BEYOND ITS LOWEST LIMIT. IT COULD NOT BE VERIFIED IF THE SPO2 SENSOR WAS NO LONGER IN PLACE OR IF A TECHNICAL ALARM OCCURRED IN RESPONSE TO A SPO2 DISCONNECT. THE CUSTOMER WAS EXPECTING A DESAT ALARM IN RESPONSE TO AN OXYGEN SATURATION DECREASED UNDER THE DESAT-LIMIT. UPON REVIEW OF THE CENTRAL DIAGNOSTIC LOGS, THERE WERE NO ENTRIES OF A DESAT ALARM AT THE TIME EVENT. WITHIN A SHORT PERIOD THEREAFTER (15 MINUTES), THESE LOGS INCLUDE ENTRIES OF SEVERAL HIGH PRIORITY PATIENT ALARMS INCLUDING DESAT ALARMS. PRIOR TO THE EVENT (AT 11:48), THERE ALSO WAS A RECORDED ENTRY WITHIN THE DIAGNOSTIC LOGS OF A DESAT ALARM EVENT. THE CUSTOMER IS UNABLE TO VERIFY IF THE SPO2 SENSOR WAS INTACT ON THE PATIENT AT THE TIME OF THE EVENT. SHOULD THE SPO2 SENSOR ACCIDENTLY FALL OFF DURING SPO2 MONITOR, IT IS EXPECTED THAT THE BEDSIDE MONITOR WILL ALERT THE USER WITH BOTH AUDIBLE/VISUAL ALARMS. THE DESAT ALARM WILL NOT OCCUR AS THERE IS NO LONGER A MEASUREMENT CONDITION FOR THE MONITOR TO EVALUATE. PER OUR LABELING, INSTRUCTIONS FOR USE, PART NUMBER M8000-9001K: INOPS ARE TECHNICAL ALARMS, THEY INDICATE THAT THE MONITOR CANNOT MEASURE OR DETECT ALARM CONDITIONS RELIABLY. IF AN INOP INTERRUPTS MONITORING AND ALARM DETECTION (FOR EXAMPLE, SPO2 DISCONNECT), THE MONITOR PLACES A QUESTION MARK IN PLACE OF THE MEASUREMENT NUMERIC AND AN AUDIBLE INDICATOR TONE WILL BE SOUNDED. STANDARD INOPS ARE INDICATED WITH A LOWER PITCHED TONE IS REPEATED TWICE, FOLLOWED BY A PAUSE. IF THE SPO2 SENSOR IS NO LONGER IN PLACE DURING SPO2 MONITORING, THE BEDSIDE MONITOR WILL ALARM "SPO2 NO SENSOR." SHOULD THIS TECHNICAL PATIENT ALARM OCCUR, THERE WILL BE NO RECORD ENTRY FOUND WITHIN EITHER THE DIAGNOSTIC LOGS OF THE BEDSIDE/CENTRAL MONITOR. BASED UPON THE INFORMATION RECEIVED, THE ROOT CAUSE FOR NO SPO2 ALARM ON (B)(6) 2011 AT 18:45 COULD NOT BE DETERMINED. HOWEVER, THE BEDSIDE MONITOR DID ELICIT SEVERAL HIGH PRIORITY DESAT ALARMS STARTING AT 19:11 WHICH INDICATE BOTH FUNCTIONALITY FOR SPO2 ALARMING AND ALSO ACKNOWLEDGEMENT BY THE CLINICIAN. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT WAS BEING MONITORED USING SPO2 PULSE OXIMETRY ONLY. THERE WAS NO ACTIVE ECG MONITORING. THE PATIENT'S SPO2 ALARM LIMIT WAS EXCEEDED BEYOND ITS LOWEST LIMIT. IT COULD NOT BE VERIFIED IF THE SPO2 SENSOR WAS NO LONGER IN PLACE OR IF A TECHNICAL ALARM OCCURRED IN RESPONSE TO A SPO2 DISCONNECT. THE CUSTOMER WAS EXPECTING A DESAT ALARM IN RESPONSE TO AN OXYGEN SATURATION DECREASED UNDER THE DESAT-LIMIT.

    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