BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR

    MDR report key: 8500822 · Received April 10, 2019

    Report

    Report Number
    9613793-2019-00002
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 10, 2019
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
    Product Code
    BZT
    UDI-DI
    50749756045990
    PMA / PMN Number
    K925789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: A ROOT CAUSE COULD NOT BE DETERMINED. THE DEFECTIVE SAMPLE WAS NOT RETURNED FOR EVALUATION, AND NO ISSUES WERE IDENTIFIED DURING A REVIEW OF QUALITY RECORDS. CORRECTIVE ACTION: DUE TO THE ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATIVE SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING AN ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (PART 81-040412, LOT 48181841) STOPPED DETECTING TEMPERATURE DURING USE, AND A SKIN PROBE HAD TO BE PULLED TO CONTINUE MONITORING THE PATIENT'S TEMPERATURE. THE DEFECTIVE SAMPLE WAS UNAVAILABLE FOR RETURN. THEREFORE, A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. THE INITIAL REPORT INDICATED REPRESENTATIVE SAMPLES FROM THE SAME LOT WERE AVAILABLE FOR RETURN. HOWEVER, AS OF THE DATE OF THIS REPORT, THOSE SAMPLES HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE REPORTED LOT NUMBER AND NO ISSUES WERE REPORTED DURING THE MANUFACTURING OR INSPECTION OF THE PRODUCT. THE BILL OF MATERIAL FOR THE WORK ORDER INVOLVED WAS REVIEWED TO IDENTIFY THE SUB-ASSEMBLY WIRE SET USED TO MANUFACTURE THE LOT. THE FUNCTIONAL RESULTS FOR THIS SUB-ASSEMBLY (LOT 48242691) WERE REVIEWED AND NO DISCREPANCIES WERE REPORTED DURING THE QUALITY INSPECTION. A FUNCTIONAL INSPECTION OF PRODUCT IN PROCESS WAS MADE. ONE-HUNDRED AND TWENTY-FIVE SAMPLES FROM WORK ORDER 48229429 WERE INSPECTED AND ALL UNITS WERE FOUND WITHIN TOLERANCE. THE 2017-2019 COMPLAINT LOG WAS REVIEWED FOR SIMILAR COMPLAINTS. TWO COMPLAINTS ((B)(4)) WERE IDENTIFIED FOR AN ESOPHAGEAL STETHOSCOPE DISPLAYING INCONSISTENT TEMPERATURE READINGS. AT THIS TIME, THESE COMPLAINTS HAVE BEEN CLOSED AND VERIFIED. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    DURING A DENTAL CASE, THE ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR STOPPED READING THE PATIENT'S TEMPERATURE. A SKIN PROBE WAS PULLED TO THE PATIENT'S TEMPERATURE COULD CONTINUE BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292867 ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS BZT DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. 81-040412 48181841 50749756045990

    Patients

    Seq Age Sex Outcome Treatment
    1