BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER (MMS)

    MDR report key: 1902572 · Received November 12, 2010

    Report

    Report Number
    9610816-2010-00703
    Event Type
    Injury
    Date Received
    November 12, 2010
    Report Date
    July 8, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS REPORT IS BEING SENT IN ABUNDANT CAUTION ONLY BECAUSE THIS BABY WAS BEING EMERGENTLY TREATED ("BABY WAS CRASHING"). THERE WAS NO LACK OF AWARENESS OF THE CLINICIANS TO THIS BABY'S CONDITION AND NEED FOR MEDICAL CARE. IT WAS DURING THIS EMERGENT CARE THAT THE CLINICIANS CHOSE AN INCOMPATIBLE 3RD PARTY SPO2 SENSOR AND ATTEMPTED TO USE IT WITH A PHILIPS MMS AND MONITOR. THE CUSTOMER REPORTED THAT THEIR NEW INTELLIVUE MULTI-MEASUREMENT SERVER (MMS), SOFTWARE REVISION G.01.72, WAS DISPLAYING AN 'SPO2 LABEL SENSOR MALF' INOP, AND WHEN USING THE SAME SENSOR ON AN INTELLIVUE PULSE OXIMETRY MODULE (M1020B), THE SENSOR WORKED FINE. THE TECHNICAL INOP WAS OBVIOUS TO USERS AND THE USER ERROR IN TRYING AN INCOMPATIBLE SENSOR POSED MINIMAL HEALTH RISK. THE CUSTOMER SENT TWO SENSORS TO PHILIPS TO BE TESTED. TESTING WAS PERFORMED AND IT WAS DETERMINED THAT THE SENSORS DID NOT MALFUNCTION PER DESIGN AND INTENT. NELLCOR SENSORS DO NOT WORK ON/WITH FAST 1 OR OPTION A02 MMSS. TWO NEW SENSORS WERE SENT TO THE CUSTOMER ONLY BECAUSE THE TESTED SENSORS COULD NOT BE RETURNED TO THE CUSTOMER. DEVICE LABELING (INSTRUCTIONS FOR USE) ADEQUATELY DESCRIBES WHICH SENSORS ARE VALIDATED/APPROVED FOR EACH OPTION OF MMS. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SENSOR WAS PROVIDING INCORRECT READING AND ERROR MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MULTI MEASUREMENT SERVER (MMS) MHX PHILIPS MEDICAL SYSTEMS M3001A

    Patients

    Seq Age Sex Outcome Treatment
    1