BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL 1 ER 400 TEMPERATURE PROBE

    MDR report key: 19304395 · Received May 13, 2024

    Report

    Report Number
    9617604-2024-00427
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 1, 2024
    Report Date
    June 25, 2024
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FLL
    PMA / PMN Number
    K863646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, BUT DAY IS UNKNOWN. D4. LOT NUMBER, EXPIRATION DATE, UDI, AND H4. MANUFACTURE DATE ARE UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    D9. DATE RETURNED TO MFG: 22-MAY-2024 H6. INVESTIGATION CODES: UPDATED INVESTIGATION SUMMARY: ONE (1) UNIT OF PART NUMBER ER400-9 WAS RECEIVED IN USED AND DECONTAMINATED CONDITION, AND WITHOUT ITS ORIGINAL PACKAGING. THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12¿ TO 16¿ UNDER NORMAL CONDITIONS OF ILLUMINATION TO DETECT SAMPLE CONDITIONS THAT COULD CAUSE FUNCTIONAL ISSUES. NO DAMAGE, CUTS OR DISCREPANCIES AFFECTING ITS PERFORMANCE WERE FOUND IN THE SAMPLE RECEIVED. AN ELECTRICAL TEST WAS PERFORMED BASED ON THE MP ER-ASSY MANUFACTURING PROCEDURE. THE UNIT PASSED THE ELECTRICAL TEST. AN ELECTRICAL TEST WAS PERFORMED BASED ON THE QP ER-ASSY QUALITY PROCEDURE. THE UNIT PASSED THE ELECTRICAL TEST. BASED ON THE FUNCTIONAL TEST RESULTS, THE REPORTED FAILURE MODE WAS NOT CONFIRMED, AND THE ROOT CAUSE WAS NOT DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TEMPERATURE COULD NOT BE MEASURED. DURING PATIENT USE, THE ANGLE WENT BACK AND FORTH BETWEEN 30 AND 37 DEGREES. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763832 LEVEL 1 ER 400 TEMPERATURE PROBE THERMOMETER, ELECTRONIC, CLINICAL FLL SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown