BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKG THERM INTL,M692,4',OR,W

    MDR report key: 19221477 · Received May 1, 2024

    Report

    Report Number
    1316463-2024-00053
    Event Type
    Injury
    Date Received
    May 1, 2024
    Date of Event
    April 9, 2024
    Report Date
    May 1, 2024
    Manufacturer
    WELCH ALLYN INC
    Product Code
    FLL
    UDI-DI
    00732094028942
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE 81 YEAR OLD PATIENT WAS ADMITTED FOR TOTAL HIP REPLACEMENT AND HAS A PAST MEDICAL HISTORY OF ASTHMA, ATRIAL FIBRILLATION HYPERTENSION AND DYSLIPIDEMIA. THE PATIENT PRESENTED TO THE ED WITH COUGHING SORE THROAT AND HEMOPTYSIS, A SCAN WAS PERFORMED, AND THE PROBE WAS REMOVED UNDER TOPICAL ANESTHETIC USING MCGILL FORCEPS. THE PATIENT WAS REPORTED TO HAVE MADE A FULL RECOVERY ONCE THE PROBE WAS REMOVED. THE SURETEMP THERMOMETER IS INTENDED TO MEASURE A PATIENT¿S TEMPERATURE IN THE ORAL, AXILLARY, AND RECTAL BODY SITES OF ADULT, PEDIATRIC, AND NEWBORN PATIENTS. ITS INSTRUCTIONS OR USE INCLUDES THE FOLLOWING WARNINGS PATIENT INJURY RISK. USE ONLY WELCH ALLYN SINGLE-USE DISPOSABLE PROBE COVERS. A NEW PROBE COVER NEEDS TO BE USED WITH EACH NEW TEMPERATURE TAKEN. NEVER TAKE A TEMPERATURE MEASUREMENT WITHOUT A SINGLE-USE PROBE COVER SECURELY ATTACHED. THE DEVICE INSTRUCTIONS PROVIDE THE FOLLOWING WARNING: USE ONLY WELCH ALLYN PROBE COVERS. THE USE OF OTHER MANUFACTURERS PROBE COVERS OR NO PROBE COVER MAY PRODUCE TEMPERATURE MEASUREMENT ERRORS AND/OR INACCURACY. ADDITIONALLY, THE IFU PROVIDES THE FOLLOWING INSTRUCTIONS FOR LOADING THE PROBE COVER ON THE TEMPERATURE PROBE: LOAD A PROBE COVER BY INSERTING THE PROBE INTO A PROBE COVER AND PRESSING THE PROBE HANDLE DOWN FIRMLY. THE PROBE HANDLE WILL MOVE SLIGHTLY TO ENGAGE THE PROBE COVER. AFTER THE TEMPERATURE MEASUREMENT IS COMPLETE, REMOVE THE PROBE FROM THE PATIENT¿S MOUTH. EJECT THE PROBE COVER BY FIRMLY PRESSING THE EJECTION BUTTON ON THE TOP OF THE PROBE. IN THIS EVENT, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED PAIN ASSOCIATED WITH A SORE THROAT AND HEMOPTYSIS. PAIN AND HEMOPTYSIS ARE NOT CONSIDERED LIFE THREATENING ALONE, HOWEVER, THE PATIENT REQUIRED MEDICAL/SURGICAL INTERVENTION FOR THE REMOVAL OF THE FOREIGN BODY IN THE GI TRACT TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT IMPAIRMENT OF A BODY STRUCTURE, WHICH CONCLUDES A SERIOUS INJURY DID OCCUR IN THIS EVENT. DETAILS PROVIDED BY THE CUSTOMER INDICATES THAT USE ERROR OCCURRED AS THE PROBE COVER WAS NOT SECURELY ATTACHED TO THE PROBE PRIOR TO THE CAREGIVER OBTAINING THE PATIENT¿S TEMPERATURE, AS THE CAREGIVER WAS ANTICIPATING A NOISE ON CONNECTION TO INDICATE THE COVER¿S ATTACHMENT. OF NOTE: THE DEVICE INSTRUCTIONS FOR USE DOES NOT STATE THAT A NOISE INDICATES THE SECURE ATTACHMENT OF THE PROBE COVER. FURTHERMORE, THE CAREGIVER FAILED TO ENSURE THE PROBE COVER DID NOT REMAIN IN THE PATIENT¿S MOUTH AND FAILED TO ENSURE THE COVER WAS EJECTED FROM THE PROBE BY PRESSING THE EJECT BUTTON FOLLOWING COMPLETION OF THE USE OF THE TEMPERATURE PROBE. ALTHOUGH THERE WAS NO DEVICE MALFUNCTION REPORTED AND THE EVENT CAN BE ATTRIBUTED TO USE ERROR, HILLROM IS REPORTING THIS SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF THE SURETEMP THERMOMETER THE DISPOSABLE TEMPERATURE PROBE COVER USED WITH THE THERMOMETER REMAINED IN THE PATIENT¿S THROAT AND WAS NOT REMOVED UNTIL THE FOLLOWING DAY. IT WAS ALSO REPORTED THAT DURING THIS EVENT, THE DOCTOR HAD UNDERTAKEN AN ORAL TEMPERATURE CHECK USING THE SAID DEVICE. THE PROBE COVER WAS NOT FULLY CONNECTED TO THIS PROBE, WHICH REQUIRES THE PLASTIC SHEATH TO BE FULLY COVERING THE PROBE AND ON CONNECTION A NOISE CAN BE HEARD AND FELT INDICATING THAT THE PROBE IS IN PLACE. REGRETTABLY THIS ACTION DID NOT RESULT. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171594 PKG THERM INTL,M692,4',OR,W THERMOMETER, ELECTRONIC, CLINICAL FLL WELCH ALLYN INC 01692-400 00732094028942

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention