BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONTAL TEMPERATURE SKIN SENSO, NOVAPLUS

    MDR report key: 23815385 · Received December 16, 2025

    Report

    Report Number
    9613793-2025-00010
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 25, 2025
    Report Date
    February 19, 2026
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
    Product Code
    FMT
    UDI-DI
    00749756927574
    PMA / PMN Number
    K200319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "THE TEMPERATURE IS NOT READING PROPERLY AND IS NOT WORKING WELL WITH GE GIRAFFE BEDS." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER, IT WAS LISTED AS NOT AVAILABLE FOR RETURN. DEROYAL COULD NOT REVIEW THE SPECIFIC DEVICE HISTORY RECORD (DHR) AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. AN INVENTORY CHECK WAS CONDUCTED ON 125 EACHES AND ALL WERE FOUND TO BE WITHIN SPECIFICATION. 125 SAMPLES THAT WERE IN-WORK WERE ALSO SUBJECTED TO FUNCTIONAL TESTING. NO DEFECTS OR ABNORMALITIES WERE FOUND. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4). ROOT CAUSE: BECAUSE THE SAMPLE NOR LOT NUMBER WERE PROVIDED AND NO ISSUES WERE IDENTIFIED WITHIN THE MANUFACTURING REVIEW, THE SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND 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.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "THE TEMPERATURE IS NOT READING PROPERLY AND IS NOT WORKING WELL WITH GE GIRAFFE BEDS." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER, IT WAS LISTED AS NOT AVAILABLE FOR RETURN. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "THE TEMPERATURE IS NOT READING PROPERLY AND IS NOT WORKING WELL WITH GE GIRAFFE BEDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2282607 NEONTAL TEMPERATURE SKIN SENSO, NOVAPLUS WARMER, INFANT RADIANT FMT DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L VHNICU-37 00749756927574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown