BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP70 INTELILVUE PATIENT MONITOR

    MDR report key: 996311 · Received February 11, 2008

    Report

    Report Number
    9610816-2008-00008
    Event Type
    Injury
    Date Received
    February 11, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 14, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS IS IN THE PROCESS OF OBTAINING MORE INFO REGARDING THIS EVENT AND THIS COMPLAINT IS STILL UNDER INVESTIGATION. AT THIS TIME PHILLIPS DOES NOT HAVE SUFFICIENT INFO TO VERIFY THAT MONITORING WAS NOT A FACTOR IN THIS SERIOUS INJURY. A SUPPLEMENTAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    AT 18.00 THE PT REQUIRED CPAP WITH AN OXYGEN NEED OF 50%. THE SATURATION DURING THE NIGHT ACCORDING TO THE SPO2 READINGS WERE 99-100%. THE OXYGEN SUPPLY WAS THEN LOWERED BASED ON THE SPO2 VALUES. AT 01.00 EXTERNAL TINA MEASUREMENT DEVICE IS SHOWING HIGH PCO2 AND LOW PO2. AN ACID - BASE SAMPLE IS TAKEN THAT SHOWS SERIOUS UNDERVENTILATION AND EXTREMELY LOW PO2 AND SATURATION IN CAPILLARY SAMPLES. SATURATION METER CONTINUES TO SHOW GOOD VALUES. A VISUAL INSPECTION SUPPORTS THAT THE BABY GIRL IS POORLY OXYGENATED. A MASSINO SENSOR WAS PLACE ON THE BABY AND SHOWS SPO2 READINGS OF 30-40%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP70 INTELILVUE PATIENT MONITOR COMPACT PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention