LEVEL 1 ER 400 TEMPERATURE PROBE

Additional Manufacturer Narrative

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.

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.