BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MON-A-THERM

    MDR report key: 8300909 · Received February 4, 2019

    Report

    Report Number
    2936999-2019-00088
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    January 10, 2019
    Report Date
    March 11, 2019
    Manufacturer
    MMJ SA DE CV(USD)
    Product Code
    BZT
    UDI-DI
    30884521031740
    PMA / PMN Number
    K811862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: ONE SAMPLE OF TEMPERATURE PROBE WAS RECEIVED FOR EVALUATION. A FUNCTIONAL TEST WAS PERFORMED ON THE THERMISTOR, USING THE LIQUID BATH. ISOTECH HYPERION 936 CALIBRATION NUMBER 14310, THE SAMPLE THERMISTOR WAS PEELED FROM THE PLASTIC SHEATH AND SUBMERGED INTO THE OIL OF THE BATH AT 37.003 CELSIUS DEGREES. THE THERMISTOR WAS CONNECTED TO THE DIGITAL MULTIMETER TO TEST ITS RESISTANCE IN THE BATH. THE READING OF THE MULTIMETER WAS 1.3548 KOHMS WHICH IS WITHIN SPECIFICATION. ACCORDING TO THE MATERIAL SPECIFICATION, NO FAILURE MODE WAS OBSERVED IN THE RECEIVED SAMPLE SINCE MET WITH THE PRODUCT SPECIFICATIONS AND NO CORRECTIVE ACTIONS ARE REQUIRED. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE UNIT FAILED TO INTERFACE CORRECTLY WITH OTHER DEVICE LEADING IN A TEMPERATURE COOLER THAT THE SET PATIENT'S TEMPERATURE. IT WAS STATED THAT THEY SWITCH OFF THE OTHER DEVICE BUT THE PATIENT'S TEMPERATURE DID NOT RISE. THERE WAS NO REPORTED PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94662 MON-A-THERM STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS BZT MMJ SA DE CV(USD) 90049 16F0730JZX 30884521031740

    Patients

    Seq Age Sex Outcome Treatment
    1