BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M3155 INFO CNTR NETWORK DB REL N.0

    MDR report key: 18170913 · Received November 20, 2023

    Report

    Report Number
    1218950-2023-00868
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 30, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GOOD FAITH EFFORT (GFE) WAS PERFORMED TO CLARIFY IF THERE WAS AN OPEN FLAME AND IF SO, IF THE FLAMES BREACHED THE CASE, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. THE CUSTOMER ADVISED THAT THE STAFF CALLED THE FIRE DEPARTMENT ONCE THEY SMELLED SMOKE. THE FIRE DEPARTMENT PINPOINTED THE SMELL COMING FROM THE PATIENT MONITORING RACK USING THEIR HEAT SENSOR. THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: THE FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND FOUND THAT THE CENTRAL HAD NO PATIENT RHYTHMS AND APPEARED TO BE IN LOCAL MODE. THE FSE WAS ABLE TO GET THE CENTRAL CONNECTED BACK TO THE DATABASE SERVER, BUT THE PATIENT RHYTHMS WERE STILL NOT COMING UP ON CENTRAL. THE FSE NOTICED SOME LIGHTS WERE OFF ON THE COMPONENT BELOW THE SWITCH, THE POE (POWER OVER ETHERNET). THE POE RAN THE ACCESS POINTS AND APPEARED TO BE BURNED OUT. THE FSE DETERMINED THAT THE POE CAUSED THE BURNING SMELL. THE FSE UNPLUGGED THE POE AT REQUEST OF NURSE MANAGER TO PREVENT ANY FURTHER BURNING SMELL. THE FSE ORDERED A COMPATIBLE SWITCH/POE FOR REPLACEMENT. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS THE POE. THE REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS OPERATIONAL AFTER REPLACING THE POE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A BURNING SMELL COMING FROM A PHILLIPS MONITORING RACK AND NO PATIENTS SHOWING UP ON THE CENTRAL. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797228 M3155 INFO CNTR NETWORK DB REL N.0 M3155 INFO CNTR NETWORK DB REL N.0 MHX PHILIPS MEDICAL SYSTEMS 865418

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown