BEUDAMED
    FDA Adverse Event Other Summary report: N

    XPER IM PHYSIOMONITORING SYSTEM

    MDR report key: 1236813 · Received October 30, 2008

    Report

    Report Number
    1039368-2008-00003
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    WITT BIOMEDICAL CORP., A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA, INC.
    Product Code
    MWI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CUSTOMER SITE. REVIEW OF LABELING WAS PERFORMED. XPER INFORMATION MANAGEMENT PRODUCT MANUAL AND ACCESSORIES, STATES "USE ONLY TYCO/NELLCOR APPROVED OXIMAX DS-100A SENSORS AND CABLES WITH THIS SYSTEM." THE SAME, INDICATES "TO ENSURE PT SAFETY, USE AND/OR CONNECT ONLY PARTS AND ACCESSORIES SPECIFIED BY PHILIPS MEDICAL SYSTEMS AS PART OF THE XPER INFORMATION MANAGEMENT SYSTEM AND SUPPLIED BY OR RECOMMENDED BY PHILIPS MEDICAL SYSTEMS." INVESTIGATION OF THE INCIDENT DEVICE WAS ALSO PERFORMED USING THE REUSABLE SPO2 PROBE NORMALLY PROVIDED WITH OUR DEVICE. THE DEVICE FUNCTIONED AS INTENDED. WE WERE UNABLE TO DUPLICATE THE DESCRIBED FAILURE. CONCLUSION: USER ERROR: CUSTOMER WAS FOUND TO BE USING AN UNAPPROVED O2 SENSOR PROBE WITH OUR SYSTEM DESPITE STATEMENTS IN THE XPER INFORMATION MANAGEMENT PRODUCT MANUAL. INFORMED USER THAT ONLY THE PARTS SENT WITH THE SYSTEM SHOULD BE USED TO ENSURE ACCURATE SPO2 READINGS.

    Description of Event or Problem · 1

    IN 2008, THE CUSTOMER CALLED STATING THAT A CRITICAL PT'S SATS WERE NOT MONITORED CORRECTLY. THE CUSTOMER STATED THAT THE PT WAS ON A BALLOON PUMP TO SUSTAIN, RECORD AND MONITOR VITALS. THEY STATED THE DEVICE, FRONT END (FE), DISPLAYED 98-100% MOST OF THE CASE, THEN NO DATA; HOWEVER, WHEN HOOKED UP ON BALLOON PUMP, THE PT'S ACTUAL SATS WERE IN THE 50S. ACCORDING TO THE CUSTOMER, DURING THE CASE, THE SPO2 READING WAS 100%; HOWEVER, THE PT'S CONDITION BEGAN DETERIORATING. ABG SHOWED BLOOD GAS OF 60, BUT SPO2 CONTINUED TO READ AS 100%. PT WAS INTUBATED. OUR FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND TESTED THE SYSTEM WITH THE NELLCOR SRC-MAX SIMULATOR AND ALL SIMULATOR SETTINGS. THE FSE NOTED THAT READINGS WERE ACCURATE; HE WAS NOT ABLE TO REPRODUCE THE PROBLEM, REPLACED THE SPO2 MODULE AS A PREVENTIVE MEASURE, RE-TESTED THE SYSTEM, AND SYSTEM PASSED ALL TESTS PERFORMED. FOUR DAYS LATER, ANOTHER FSE VERIFIED SPO2 ACCURACY AT 75% AND 90% SATURATION; READINGS WERE ACCURATE. THE CUSTOMER REPORTED THAT THE CASE IN WHICH THE SPO2 READING WAS INACCURATE, THEY WERE USING A NELLCOR "MAX-A" DISPOSABLE SPO2 PROBE INSTEAD OF THE REUSABLE PROBE THAT WAS SUPPLIED BY IPC WITH THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPER IM PHYSIOMONITORING SYSTEM XPER IM PHYSIOMONITORING 5 MWI WITT BIOMEDICAL CORP., A WHOLLY OWNED SUBSIDIARY OF PHILIPS HOLDING USA, INC. XPER IM FRONT END NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other