BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL PURPOSE PROBE, 400 SERIES 9 FR (+/-0.2)

    MDR report key: 19950015 · Received August 9, 2024

    Report

    Report Number
    9613793-2023-00014
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    June 27, 2023
    Report Date
    July 25, 2023
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
    Product Code
    FLL
    UDI-DI
    00749756984072
    PMA / PMN Number
    K925791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "TEMPERATURE PROBE IS NOT SHOWING THE RIGHT TEMPERATURE AND VERY SENSITIVE WHEN MOVING THE PROBE." THE SAMPLE WAS REQUESTED FROM VYAIRE, BUT IT COULD NOT BE RETURNED. BECAUSE NO SAMPLE COULD BE RETURNED, FUNCTIONAL TESTING COULD NOT BE PERFORMED ON THE DEFECTIVE SAMPLE. DEROYAL INDUSTRIES REVIEWED 200 WORK ORDERS, THE FAILURE MODES AND EFFECTS ANALYSIS (FMEA), AND THE DEVICE HISTORY RECORD AND NO ISSUES WERE FOUND. AN INVENTORY CHECK WAS PERFORMED ON 125 PROBES AND ALL WERE FOUND TO BE ACCEPTABLE. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4) %. ROOT CAUSE: BECAUSE A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED ON THE DEFECTIVE SAMPLE AND NO ISSUES WERE IDENTIFIED IN DOCUMENTATION ON HAND, NO ROOT CAUSE CAN BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTION: BECAUSE NO ROOT CAUSE COULD BE DETERMINED, DEROYAL HAS NOT TAKEN ANY CORRECTIVE OR PREVENTIVE ACTIONS. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS SURROUNDING THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED "THE TEMPERATURE PROBE IS NOT SHOWING THE RIGHT TEMPERATURE AND IS VERY SENSITIVE WHEN MOVING THE PROBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174686 GENERAL PURPOSE PROBE, 400 SERIES 9 FR (+/-0.2) THERMOMETER, ELECTRONIC, CLINICAL FLL DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L M1024229VY 58173385 00749756984072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown