BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHAGEAL STETHOSCOPE SOFT TUBE WITH TEMPERATURE SENSOR

    MDR report key: 12120705 · Received July 6, 2021

    Report

    Report Number
    9613793-2021-00014
    Event Type
    Malfunction
    Date Received
    July 6, 2021
    Date of Event
    June 8, 2021
    Report Date
    July 6, 2021
    Product Code
    BZT
    UDI-DI
    00749756045964
    PMA / PMN Number
    K193027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE WAS UNDETERMINED. DEFECTIVE SAMPLE WAS TO BE RECEIVED; HOWEVER, THE DEVICE WAS NOT LOCATED BY THE CUSTOMER; THEREFORE, IT WAS NOT POSSIBLE TO PERFORM FURTHER INSPECTION. FAILURE MODE EFFECTIVE ANALYSIS (FMEA) ON FILE WAS REVIEWED AND IT WAS CONFIRMED THAT THERE IS ALREADY A FAILURE MODE IDENTIFIED RELATED TO THE ISSUE UNDER INVESTIGATION, AND CONTROLS HAVE BEEN IMPLEMENTED BY THE MANUFACTURING PLANT'S PROCEDURE IN RELATION TO QUALITY INSPECTION. COMPLAINT LOG OF THE LAST TWO YEARS WAS REVIEWED AND IT WAS CONFIRMED THAT NO SIMILAR ISSUES OF THE SAME PART NUMBER HAVE BEEN REPORTED. ACCORDING TO THE BILL OF MATERIAL OF THE PRODUCT INVOLVED, THIS FINISHED GOOD IS USED IN A SUB-ASSEMBLY, MATERIAL IN PROCESS OF THIS PRODUCT WAS INSPECTED, FUNCTIONAL RESULTS ((B)(4)) OF THE WORK ORDER WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RESULTS WERE FOUND WITHIN THE TOLERANCE. 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 · 1

    PATIENT REACHED APPROPRIATE RANGE (36.5-37.0 DEGREES CELSIUS AT APPROXIMATELY 1815 HOURS. AT APPROXIMATELY 1850 HOURS, ESOPHAGEAL TEMPERATURE READING PER BLANKETROL WAS READING 33.1 DEGREES CELSIUS. PER BLACK MARKING ON ESOPHAGEAL PROBE, PROBE DID NOT BECOME DISLODGED OR MOVE. AXILLARY TEMPERATURE 37.8 DEGREES CELSIUS AND 37.8 DEGREES CELSIUS RECTAL TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016506 ESOPHAGEAL STETHOSCOPE SOFT TUBE WITH TEMPERATURE SENSOR ESOPHAGEAL STETHOSCOPE BZT 81-050409 00749756045964

    Patients

    Seq Age Sex Outcome Treatment
    1