BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN TEMPERATURE PROBE, 400 SERIES

    MDR report key: 19960641 · Received August 12, 2024

    Report

    Report Number
    9613793-2024-00003
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    May 15, 2024
    Report Date
    July 8, 2024
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
    Product Code
    FLL
    UDI-DI
    00749756046169
    PMA / PMN Number
    K200631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, " PRE-OP PATIENT TEMP IS TAKEN MANUALLY. INTRA-OP PATIENT TEMP IS MONITORED BY DEROYAL'S SKIN TEMP SENSOR IN AXILLARY LOCATION, ROUTINELY OFF BY 4 DEGREES. POST-OP TEMP IS TAKEN MANUALLY." DEROYAL HAS REQUESTED RETURN OF A SAMPLE, BUT IT HAS NOT YET BEEN PROVIDED. THE 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.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, " PRE-OP PATIENT TEMP IS TAKEN MANUALLY. INTRA-OP PATIENT TEMP IS MONITORED BY DEROYAL'S SKIN TEMP SENSOR IN AXILLARY LOCATION, ROUTINELY OFF BY 4 DEGREES. POST-OP TEMP IS TAKEN MANUALLY." DEROYAL REQUESTED RETURN OF A SAMPLE AND RECEIVED IT ON MAY 11, 2024. THE SAMPLE WAS TESTED ACCORDING TO THE SPECIFICATIONS AND CONFIRMED TO BE WITHIN THE DESIGNATED SPECS. THE DEVICE HISTORY RECORD FOR THE DEVICE WAS REVIEWED AND IT WAS CONFIRMED THAT NO ISSUES WERE NOTED IN MANUFACTURING OR INSPECTION. SUBASSEMBLY LOTS OF THE DEVICE WERE ALSO REVIEWED AND NO FUNCTIONAL ISSUES WERE FOUND. INVENTORY OF 125 EACHES WERE INSPECTED AND NO FUNCTIONAL ISSUES WERE IDENTIFIED. RISK DOCUMENTS AND MATERIAL REVIEW REPORTS WERE REVIEWED AND DID NOT REQUIRE ANY UPDATES OR ADDITIONS. (B)(4). ROOT CAUSE: BECAUSE NO ISSUES WERE FOUND WITH THE RETURNED SAMPLE OR DOCUMENTATION OF THE MANUFACTURING PROCESS, NO ROOT CAUSE COULD BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTION: BECAUSE NO ROOT CAUSE COULD BE ESTABLISHED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. THE 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, " PRE-OP PATIENT TEMP IS TAKEN MANUALLY. INTRA-OP PATIENT TEMP IS MONITORED BY DEROYAL'S SKIN TEMP SENSOR IN AXILLARY LOCATION, ROUTINELY OFF BY 4 DEGREES. POST-OP TEMP IS TAKEN MANUALLY. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780483 SKIN TEMPERATURE PROBE, 400 SERIES THERMOMETER, ELECTRONIC, CLINICAL FLL DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L 81-010400 60393328 00749756046169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown