BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MULTI MEASUREMENT SERVER (MMS)

    MDR report key: 2213125 · Received August 4, 2011

    Report

    Report Number
    9610816-2011-00462
    Event Type
    Death
    Date Received
    August 4, 2011
    Report Date
    July 30, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A DEATH, AND THE USE OF THE DEVICE MAY HAVE BEEN A FACTOR IN THE DEATH. THE CUSTOMER REPORTED THAT THEY HAVE TWO DIFFERENT VERSIONS OF THE M3001A MULTI-MEASUREMENT MODULE (MMS); NEWER M3001A OPTION A01 DEVICES WITH FAST SPO2 ALGORITHM, AND OLDER M3001A OPTION AO2 DEVICES. TO USE NELLCOR OXIMAX SENSORS ON THE M3001A OPTION A02, THE (B)(4) ADAPTER CABLE ONLY MUST BE USED. FOR THE NEWER M3001A OPTION A01, EITHER THE (B)(4) OR THE (B)(4) ARE REQUIRED FOR USE WITH NELLCOR OXIMAX SENSORS. A USER USED THE INCORRECT ADAPTER CABLE, NOT THE ONE SPECIFIED IN THE PRODUCT LABELING. THE CUSTOMER ALLEGES A PT SAFETY ISSUE BECAUSE THEY ARE ABLE TO CONNECT INCOMPATIBLE ADAPTER CABERS TO THE SENSOR SOCKETS, AS THEY ARE NOT DIFFERENTLY KEYED, AND THEREFORE PHYSICALLY CAN BE ATTACHED. THE PRODUCT LABELING. PHILIPS INTELLIVUE MP20-90 PT MONITOR INSTRUCTIONS FOR USE, PART NUMBER (B)(4), ON PAGE 408, CONTAINS THE FOLLOWING TEXT IN THE ACCESSORIES CHAPTER. "MAKE SURE THAT YOU USE ONLY THE ACCESSORIES THAT ARE SPECIFIED FOR USE WITH THIS DEVICE, OTHERWISE PT INJURY CAN RESULT. OPTION A01 IS THE PHILIPS FAST-SPO2 VERSION; OPTION A02 IS THE NELLCOR OXIMAX-COMPATIBLE VERSION." ALSO, THE SAME INSTRUCTIONS FOR USE SPECIFIES WHICH SENSORS WORK WITH WHICH MMS OPTION AND ADAPTER CABLE COMBINATION. ON PAGE 410, THE ADAPTER CABLES REQUIRED FOR THE NELLCOR OXIMAX SENSORS ARE SPECIFIED FOR OPTION A01 AND A02: "OPTION A01: USE ADAPTER CABLE (B)(4). OPTION A02: MUST USE ADAPTER CABLE (B)(4)." IF THE WRONG ADAPTER CABLE IS CONNECTED TO THE MMS DEVICE, AS A MITIGATION REQUIRED BY THE RISK MANAGEMENT SUMMARY (RMS), THE DEVICE AND THE MONITORING EQUIPMENT IS DESIGNED TO GENERATE AND ISSUE AN AUDIBLE AND VISUAL INOP FOR AN UNK SENSOR. THE PRODUCT LABELING DESCRIBES THE INOP ON PAGE 100: "<SPO LABEL> UNK. SENSOR - NUMERIC IS REPLACED BY A -?-. THE CONNECTED SENSOR OR ADAPTER CABLE IS NOT SUPPORTED BY THE SPO2 MEASUREMENT. USE ONLY SPECIFIED SENSORS AND CABLES." THE SAFETY RISK ASSOCIATED WITH THIS DEVICE AS EVALUATED IN THE RMS IS AN ACCEPTABLE SAFETY RISK. THE AVAILABLE EVIDENCE SUPPORTS THAT THE DEVICE DESIGN DOES NOT PRESENT A SAFETY RISK. HOWEVER, THE USE OF THE INCORRECT ACCESSORIES BY THE USER, AS WELL AS A FAILURE TO RESPOND TO LACK OF MONITORING AND A TECHNICAL INOP, MAY HAVE BEEN A CONTRIBUTORY FACTOR IN THE DEATH REPORTED IN THIS CASE. PHILIPS IS IN THE PROCESS OF OBTAINING ADD'L INFO REGARDING THIS INCIDENT 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 A DEATH, AND THE USE OF THE DEVICE MAY HAVE BEEN A FACTOR IN THE DEATH.

    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