MalfunctionFMT
PANDA IRES WARMER
Received Jan 28, 2026
Report 2112667-2026-00589 · MDR key 24203366
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SOUTH PANEL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE PANEL WAS RECOMMENDED FOR REPLACEMENT TO RESOLVE THE ISSUE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. B3 INCIDENT DATE NOT PROVIDED. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.