BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPH STETH 400 SERIES 18 FR, 400 SERIES = 2 PRONGS

    MDR report key: 19951451 · Received August 9, 2024

    Report

    Report Number
    9613793-2023-00018
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    November 10, 2023
    Report Date
    November 28, 2023
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L
    Product Code
    BZT
    UDI-DI
    00749756045988
    PMA / PMN Number
    K193027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DISTRIBUTING FACILITY REPORTED, "SENSOR MALFUNCTION. THE MACHINE COULD NOT READ THE TEMPERATURE." DEROYAL INDUSTRIES REQUESTED RETURN OF THE SAMPLE, HOWEVER, IT HAS NOT YET BEEN RETURNED. DEROYAL REVIEWED WORK ORDERS AND FAILURE MODE AND EFFECTS ANALYSIS (FMEAS) AND NO ISSUES WERE FOUND. AN INVENTORY CHECK WAS COMPLETED ON 125 ESOPHAGEAL STETHOSCOPES AND ALL WERE WITHIN SPECIFICATION. A COMPLAINT TO SALES RATIO WAS CALCULATED AND WAS FOUND TO BE (B)(4). ROOT CAUSE: BECAUSE THE DEVICE WAS NOT RETURNED AND NO ISSUES OR DISCREPANCIES WERE IDENTIFIED WITH PRODUCT RECORDS, THE ROOT CAUSE COULD NOT BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE NO ROOT CAUSE WAS DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ISSUE AND ITEM. 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 DISTRIBUTING FACILITY REPORTED, "SENSOR MALFUNCTION. THE MACHINE COULD NOT READ THE TEMPERATURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246826 ESOPH STETH 400 SERIES 18 FR, 400 SERIES = 2 PRONGS STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS BZT DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L 81-040418 56992951 00749756045988

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown