BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESSION PATIENT MONITOR (MR400)

    MDR report key: 17684150 · Received September 5, 2023

    Report

    Report Number
    1051786-2023-00010
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 11, 2023
    Manufacturer
    INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS
    Product Code
    MWI
    UDI-DI
    00884838039131
    PMA / PMN Number
    K15230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE TO EVALUATE THE DEVICE IN QUESTION. THE FSE CONFIRMED THERE WAS NO ACTUAL DELAY OR FALSE LOW READING, AND THE WAVEFORM WAS OK. THE FSE REPORTED THERE WAS AN INOPERATIVE MESSAGE PRESENT THAT READ, "INOPERATIVE SENSOR". THE FSE OBSERVED THE SENSOR WAS BEING WORN ON THE BIG TOE AND THAT THE ADAPTER WOULD BE SLIGHTLY RAISED COMPARED TO A NEW ADAPTER (NOT WORN) WHICH COULD BE THE CAUSE OF THE READING ERRORS. THE INFRARED BEAM EMITTER AND RECEIVER MAY NO LONGER BE ALIGNED WHEN USED IN THIS MANNER. THE CUSTOMER ALSO REPORTED THE SENSOR WAS ATTACHED TO THE BIG TOE WHEN THE EVENT OCCURRED. THE FSE RECOMMENDED THE ADAPTER NEXT TIME BE WORN ON THE FINGERS (HAND). THE CUSTOMER WAS PROVIDED WITH AN EXTRA DEVICE FOR BACK UP. THE KEY MARKET'S FOLLOWED-UP RESPONSE CONFIRMED THE SPO2 ADAPTER WAS NOT DEFECTIVE. THE CLIP WAS CONNECTED TO THE PATIENT'S BIG TOE, WHICH CAUSED THE READING FAILURES. AFTER THE NURSE CONNECTED THE ADAPTER TO THE FINGER, THE READINGS WERE CORRECT.BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED TO BE USER ERROR. BASED ON THE INFORMATION PROVIDED IN THE CASE AND BY KEY MARKET, IT WAS CONFIRMED THERE WAS NO ISSUE WITH THE DEVICE. THE CLIP WAS CONNECTED TO THE PATIENT'S BIG TOE, WHICH CAUSED THE READING FAILURES. AFTER THE NURSE CONNECTED THE ADAPTER TO THE FINGER, THE READINGS WERE CORRECT. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED WITH REFERENCE TO MANUFACTURER'S REPORT NUMBER 1051786-2023-00010. THE SERIAL NUMBER OF THE DEVICE PREVIOUSLY REPORTED IS INCORRECT . THE ACTUAL SERIAL NUMBER OF THE DEVICE IS CURRENTLY UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, THE CASE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN PROCESS OF OBTAINING ADDITIONAL INFORMATION. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE SHOWS A VALUE ABOVE THE EXPECTED VALUE FOR SPO2. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638713 EXPRESSION PATIENT MONITOR (MR400) EXPRESSION PATIENT MONITOR (MR400) MWI INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS 866185 00884838039131

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown