BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4003409

    MDR report key: 18039130 · Received October 31, 2023

    Report

    Report Number
    1218950-2023-00830
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 20, 2023
    Report Date
    July 19, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    D4: PRODUCT UDI - THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016, THEREFORE NO UDI.

    Additional Manufacturer Narrative · 0

    DIAGNOSTIC/FUNCTIONAL TESTING WAS PERFORMED AT THE PHILIPS AUTHORIZED REPAIR FACILITY. RESULTS OF FUNCTIONAL TESTING INDICATE THAT THE SPEAKER PRODUCED SOUND. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. ALTHOUGH THE SPEAKER WAS CONFIRMED TO BE FUNCTIONING PER SPECIFICATION DURING TESTING IT WAS INDICATED THAT THERE WAS NO SOUND AT THE TIME OF THE EVENT, THE SPEAKER HAS BEEN REPLACED PER CURRENT PROCESS. THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    THE CUSTOMER BIOMED REPORTED THAT THE FRONT BEZEL IS BROKEN, THERE ARE NO SOUNDS COMING FROM THE DEVICE DURING BOOTUP, AND THE TOUCHSCREEN IS INTERMITTENT. THE DEVICE IS PENDING BENCH REPAIR. THE DEVICE WAS NOT IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125016 4003409 4003409 DSI PHILIPS MEDICAL SYSTEMS 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown