BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEONTAL TEMPERATURE SKIN SENSO, SKIN SENSOR 3PIN, PROBE 12

    MDR report key: 19940403 · Received August 8, 2024

    Report

    Report Number
    9613793-2023-00010
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    May 30, 2023
    Report Date
    July 13, 2023
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
    Product Code
    FMT
    UDI-DI
    00749756671361
    PMA / PMN Number
    K200319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED THAT "BABY GOT HOT" WHEN USING THE HNICU-37 PROBE. A SAMPLE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RETURNED TO DEROYAL. THIS REPORT CAME IN AS ONE COMPLAINT, BUT BECAUSE IT DESCRIBED SEVEN SEPARATE EVENTS, IT WILL BE REPORTED FOR EACH EVENT. THIS REPORT IS FOUR OF SEVEN (4/7). THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE MORE INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED THAT "BABY GOT HOT" WHEN USING THE HNICU-37 PROBE. FOR THE SEVEN COMPLAINTS FILED, SEVEN LOTS WERE LISTED. SAMPLES WERE REQUESTED FOR THESE COMPLAINTS, HOWEVER ONLY SAMPLES FROM ONE LOT WERE RETURNED. A SAMPLE FROM LOT 56626811 WAS NOT RETURNED. THIS REPORT CAME IN AS ONE COMPLAINT, BUT BECAUSE IT DESCRIBED SEVEN SEPARATE EVENTS, IT WILL BE REPORTED FOR EACH EVENT. THIS REPORT IS FOUR OF SEVEN (4/7). FUNCTION RESULTS OF THE WORK ORDERS PULLED WERE REVIEWED AND IT WAS CONFIRMED THAT NO DISCREPANCIES WERE REPORTED DURING THE MANUFACTURING PROCESS. DEROYAL COMPLETED AN INVENTORY CHECK ON 125 PROBES AND ALL WERE FOUND TO BE ACCEPTABLE. A REVIEW OF WORK ORDERS OF 100 CASES WERE ALSO REVIEWED AND NO ISSUES WERE FOUND. THE DEVICE HISTORY RECORD WAS ALSO REVIEWED AND NO ISSUES WERE IDENTIFIED. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS. FROM THAT TIME PERIOD, A COMPLAINT RATIO OF (B)(4) WAS FOUND. TESTING OF THE ONE OF THE RETURNED DEVICES FROM A DIFFERENT LOT DID REVEAL A GRINDING MANUFACTURING ERROR SHOWING THE WIRE SET WAS GRINDED ABOVE THE MAXIMUM LIMIT. WHILE THIS ISSUE WAS CONCLUDED FOR THE DEVICE WITH LOT NUMBER 58195314, THE SPECIFIC DEVICE FOR LOT 56626811 WAS NOT RETURNED. BECAUSE THE DEVICE WAS NOT RETURNED AND NO ISSUES WERE FOUND WITHIN THE MANUFACTURING PROCESS OR INVENTORY, NO ROOT CAUSE COULD BE DETERMINED. 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 MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    BABY GOT HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069496 NEONTAL TEMPERATURE SKIN SENSO, SKIN SENSOR 3PIN, PROBE 12 WARMER, INFANT RADIANT FMT DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L HNICU-37 57174052 00749756671361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other