MalfunctionISA
QUANTUM INTERSEGMENTAL TABLE
Received Mar 16, 2026
Report 3007278668-2026-00003 · MDR key 24611722
Device
Product problems
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE HEATING FUNCTION WAS DISABLED.
Description of Event or Problem
THE PRODUCT'S HEAT FUNCTION HAD MALFUNCTIONED. IT OCCURRED YEARS AGO, DATE UNKNOWN. THERE WAS NO PATIENT INJURY. HOWEVER OTHER REPORTS OF A SIMILAR INCIDENT INDICATED POTENTIAL SAFETY RISK SO REPORT IS SUBMITTED.
Remedial action
- Recall