MAUDE Adverse Event Report: WELCH ALLYN INC PKG THERM INTL,M692,4',OR,W; THERMOMETER, ELECTRONIC, CLINICAL

Model Number	01692-400
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
Customer reported probe was hot.This incident was captured under hillrom complaint ref #(b)(4).
Additional Manufacturer Narrative
The customer reported that the probe was hot.There were no allegations of injury.The welch allyn suretemp plus is a portable thermistor thermometer used for accurately measuring body temperatures at oral, axillary, or rectal sites.The device was not returned for inspection.There was no reported patient involvement or injury in this complaint, however, as this event could potentially lead to a serious injury if it were to recur, baxter considers this complaint reportable.
Event or Problem Description
Customer reported probe was hot.This incident was captured under hillrom complaint ref#: (b)(4).

• Brand Name: PKG THERM INTL,M692,4',OR,W
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 21127846
• Report Number: 1316463-2025-00008
• Device Sequence Number: 7583023
• Product Code: FLL
• UDI-Device Identifier: 00732094028942
• UDI-Public: 732094028942
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 01692-400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown