BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHAGEAL STETHOSCOPE

    MDR report key: 7076510 · Received December 1, 2017

    Report

    Report Number
    9613793-2017-00007
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 2, 2017
    Report Date
    December 1, 2017
    Manufacturer
    DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
    Product Code
    BZT
    PMA / PMN Number
    K925789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: A ROOT CAUSE COULD NOT BE IDENTIFIED DUE TO THE ABSENCE OF A DEFECTIVE SAMPLE FOR TESTING. IF A DEFECTIVE SAMPLE IS RECEIVED, THIS COMPLAINT INVESTIGATION WILL BE REOPENED. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS NOT BEEN TAKEN DUE TO THE ROOT CAUSE DETERMINATION. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING THAT AN ESOPHAGEAL STETHOSCOPE (FINISHED GOOD 81-040418, LOT 42823110) WAS DETECTING INCONSISTENT TEMPERATURE VALUES, WHICH THE END USER REPORTED POSED A SAFETY CONCERN TO PATIENTS. A DEFECTIVE SAMPLE WAS INITIALLY REPORTED TO BE AVAILABLE FOR EVALUATION. AS OF THE DATE OF THIS REPORT, A SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURING FACILITY. THE WORK ORDER FOR THE REPORTED LOT NUMBER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. FUNCTIONAL RESULTS FOR ALL SUB-ASSEMBLY WORK ORDERS WERE REVIEWED AND ALL WERE FOUND TO BE WITHIN SPECIFICATION. A TWO-YEAR REVIEW OF COMPLAINTS FOR THE REPORTED FINISHED GOOD WERE REVIEWED. NO SIMILAR ISSUES HAVE BEEN REPORTED DURING THAT TIME PERIOD. A FUNCTIONAL INSPECTION OF MATERIAL IN PROCESS WAS CONDUCTED. ALL RESULTS WERE WITHIN SPECIFICATION. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN DUE TO THE ROOT CAUSE DETERMINATION. 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

    THE ESOPHAGEAL STETHOSCOPES RECENTLY HAVE BEEN DISPLAYING INCONSISTENT VALUES, WHICH THE END USER STATES IS A SAFETY CONCERN FOR PATIENTS. IN ONE INSTANCE, ONE OF THE PROBES HAD BEEN READING A TEMPERATURE OF 36, WHILE THE ORAL THERMOMETER COMPARISON WAS READING >38 DEGREES. THE PATIENT'S BODY WAS ACTUALLY EXTREMELY WARM. IN OTHER INSTANCES, A SIGNIFICANT DROP IN BODY TEMPERATURE HAD BEEN NOTED DURING BOLUS FEEDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854037 ESOPHAGEAL STETHOSCOPE STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS BZT DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. 81-040418 42823110

    Patients

    Seq Age Sex Outcome Treatment
    1