BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEO. TEMP PROBE 12 PINK, FOR USE WITH NI CABLE

    MDR report key: 19950682 · Received August 9, 2024

    Report

    Report Number
    9613793-2023-00016
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 14, 2023
    Report Date
    August 2, 2023
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
    Product Code
    FMT
    UDI-DI
    00749756885447
    PMA / PMN Number
    K925006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "BABY TEMPERATURE IS READING HYPOTHERMIC AND IT IS GETTING THE BABIES TOO HOT" A SAMPLE WAS REQUESTED TO BE RETURNED TO DEROYAL INDUSTRIES BUT WAS NOT ABLE TO BE RETURNED. DEROYAL REVIEWED FAILURE MODES AND EFFECTS ANALYSIS (FMEA) AND CORRECTIVE ACTION AND PREVENTIVE ACTION AND FOUND NO ISSUES. AN INVENTORY CHECK WAS PERFORMED ON 125 PROBES AND NO ISSUES WERE FOUND. (B)(4). ROOT CAUSE: BECAUSE NO SAMPLE WAS RETURNED AND IT WAS NOT POSSIBLE TO PERFORM AN INSPECTION OF THE LOT INVOLVED, A ROOT CAUSE COULD NOT BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: NO ACTIONS WERE TAKEN AS THE ROOT CAUSE COULD NOT BE IDENTIFIED. 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 ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "BABY TEMPERATURE IS READING HYPOTHERMIC AND IT IS GETTING THE BABIES TOO HOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2201066 NEO. TEMP PROBE 12 PINK, FOR USE WITH NI CABLE WARMER, INFANT RADIANT FMT DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L FNICU-37 00749756885447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other