MalfunctionISA
QUANTUM INTERSEGMENTAL TABLE
Received Mar 10, 2026
Report 3007278668-2026-00001 · MDR key 24564302
Device
Product problems
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE PRODUCT'S HEAT FUNCTION HAD MALFUNCTIONED. IT OCCURRED A NUMBER OF YEARS BEFORE BEING REPORTED SO THERE ARE NO DETAILS. HOWEVER OTHER REPORTS OF A SIMILAR INCIDENT INDICATED POTENTIAL SAFETY RISK SO REPORT IS SUBMITTED.
Additional Manufacturer Narrative
THE HEATING FUNCTION WAS DISABLED.
Remedial action
- Recall