PKG THERM INTL,M692,4',OR,W
Received Jan 10, 2025 · Event occurred Oct 3, 2024
Report 1316463-2025-00008 · MDR key 21127846
Device
Product problems
- Excessive Heating
- Excessive Heating
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
CUSTOMER REPORTED PROBE WAS HOT. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF#: (B)(4).
Additional Manufacturer Narrative
INSPECTION OF THE DEVICE IS PENDING AND RESULTS WILL BE PROVIDED BY A FINAL REPORT.
Description of Event or Problem
CUSTOMER REPORTED PROBE WAS HOT. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF #(B)(4).