CHATTANOOGA
Received Dec 2, 2025 · Event occurred Nov 3, 2025
Report 9616086-2025-00071 · MDR key 23700710
Product problems
- Smoking
- Temperature Problem
- Smoking
- Temperature Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE UNIT OVERHEATING ON LOW THERMOSTAT SETTING, REPORTED THAT ON MONDAY (B)(6) 2025 THE FOOTBALL COACH STATED THAT HE WALKED INTO THE TRAINING ROOM AND SAW BLACK SMOKE COMING FROM THE HYDROCOLLATOR. HE OPENED IT UP AND SMOKE CAME ROLLING OUT. IT WAS UNPLUGGED AND IT WAS TAKEN OUTSIDE, FIRE DEPARTMENT WAS CONTACTED AND THEY DID NOT HAVE A REPORT, NO INJURY OR DAMAGES OCCURRED AT THE TIME OF THE INCIDENT.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE UNIT OVERHEATING ON LOW THERMOSTAT SETTING, REPORTED THAT ON MONDAY (B)(6) 2025 THE FOOTBALL COACH STATED THAT HE WALKED INTO THE TRAINING ROOM AND SAW BLACK SMOKE COMING FROM THE HYDROCOLLATOR. HE OPENED IT UP AND SMOKE CAME ROLLING OUT. IT WAS UNPLUGGED AND IT WAS TAKEN OUTSIDE, FIRE DEPARTMENT WAS CONTACTED AND THEY DID NOT HAVE A REPORT, NO INJURY OR DAMAGES OCCURRED AT THE TIME OF THE INCIDENT. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT IF NEW INFORMATION BECOMES AVAILABLE.