BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO-TEMP 13 NEONATAL PROBE, YELLOW, PROBE 13

    MDR report key: 19931705 · Received August 7, 2024

    Report

    Report Number
    9613793-2023-00005
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    March 1, 2023
    Report Date
    July 3, 2023
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
    Product Code
    FMT
    UDI-DI
    00749756666688
    PMA / PMN Number
    K200319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE HAS BEEN REQUESTED AND WAS RETURNED TO DEROYAL INDUSTRIES ON (B)(6) 2023 TO BE TESTED. DEROYAL REVIEWED PRODUCTION LOGS AND IT WAS CONFIRMED NO SIMILAR ISSUES WERE REPORTED. WORK ORDERS, VALIDATIONS, AND FAILURE MODES AND EFFECTS ANALYSIS (FMEA)'S WERE ALSO REVIEWED. (B)(4). ROOT CAUSE: THE RETURNED COMPLAINT SAMPLES WERE FOUND TO HAVE DIMENSIONAL VARIATIONS FROM THE DIMENSIONS TO THE DESIGN PREVIOUSLY PURCHASED FROM AN OUTSIDE VENDOR. THE FOLLOWING CORRECTIVE ACTION HAS BEEN CONDUCTED BY DEROYAL: WHILE THIS DIMENSIONAL DIFFERENCE WAS FOUND TO BE IN SPECIFICATION WITH THE VERIFIED AND VALIDATED DESIGN, THE HNICU-38 MOLD IS BEING RETOOLED TO CLOSER ALIGN WITH THE PREVIOUSLY PURCHASED HNICU-38 DESIGN. APPROPRIATE VERIFICATION AND VALIDATION WILL BE COMPLETED FOLLOWING THE MOLD UPDATE. AN INVENTORY CHECK OF 53 CASES WAS MADE AND DETERMINED TO BE CONSISTENT. ALL INVENTORY SAMPLES, INCLUDING THE RETURNED SAMPLES, THAT WERE MEASURED WERE FOUND TO HAVE SLIGHTLY DIFFERENT DIMENSIONS THAN PREVIOUSLY PURCHASED HNICU-38 DESIGN. THIS WAS NOTED NOT TO BE A PRODUCTION ERROR. THE DESIGN OF THE DEROYAL DESIGNED PRODUCT WAS VERIFIED AND VALIDATED BEFORE SWITCHING FROM THE PURCHASED PRODUCT. AS PART OF THE DESIGN OF THIS PRODUCT, IF A PLUG WERE TO PULL OUT AND STOP MONITORING TEMPERATURE, A MITIGATION IS THAT THE INFANT MONITORS ARE SET TO ALARM BOTH VISUALLY AND AUDITORILY TO WARN MEDICAL PROFESSIONALS THAT THE PROBE IS NO LONGER MONITORING THE TEMPERATURE OF THE INFANTS. BECAUSE THE DESIGN OF THIS PRODUCT HAS BEEN VALIDATED AND THIS IS THE ONLY COMPLAINT OF ITS TYPE SINCE BRINGING THE MANUFACTURED PRODUCT TO THE FIELD, IT WAS DETERMINED THAT THIS ISSUE IS NOT SYSTEMIC OR DUE A MANUFACTURING ERROR. TO MORE CLOSELY ALIGN WITH MARKET EXPECTATIONS OF THIS PRODUCT, DEROYAL IS UPDATING THE MOLD TO BE MORE CLOSELY MATCH WITH THE PREVIOUSLY PURCHASED VERSION. THE RECEIPT OF THIS COMPLAINT DID NOT IDENTIFY A RISK THAT REQUIRES NEW MITIGATION AS IT IS ALREADY MITIGATED BY THE ALARM PROCESS THAT OCCURS IF TEMPERATURE IS NOT BEING MONITORED FOR ANY REASON, INCLUDING A PLUG BEING DISLODGED. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS FOR THIS ISSUE AND THIS PRODUCT. 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 ON 03/01/2023, THAT "CONNECTOR ON THE END OF PROBE WAS FALLING OUT OF THE MACHINE EITHER DURING INITIAL USE OR AFTER A FEW HOURS. BABIES TEMPERATURES WERE NOT MONITORED ALLOWING OPPORTUNITY FOR SEVERE DANGER OF OVERHEATING TO BABIES. PLUG WOULD ALSO REGISTER ERROR SIGN SOMETIMES WHEN PLUGGED INTO MACHINE. DO NOT HAVE SAMPLES OF ACTUAL DEFECTIVE PRODUCTS USED." A SAMPLE HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RETURNED TO DEROYAL INDUSTRIES. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    CONNECTOR ON THE END OF PROBE WAS FALLING OUT OF THE MACHINE EITHER DURING INITIAL USE OR AFTER A FEW HOURS. BABIES TEMPERATURES WERE NOT MONITORED ALLOWING OPPORTUNITY FOR SEVERE DANGER OF OVERHEATING TO BABIES. PLUG WOULD ALSO REGISTER ERROR SIGN SOMETIMES WHEN PLUGGED INTO MACHINE. DO NOT HAVE SAMPLES OF ACTUAL DEFECTIVE PRODUCTS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517220 HYDRO-TEMP 13 NEONATAL PROBE, YELLOW, PROBE 13 WARMER, INFANT RADIANT FMT DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L HNICU-38 58173289 00749756666688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown