MalfunctionFMT
GIRAFFE IRS
Received Mar 4, 2026 · Event occurred Feb 4, 2026
Report 3036470679-2026-00019 · MDR key 24512111
Device
Product problems
- No Flow
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING SERVICE RESULTING IN LOSS OF OXYGEN THERAPY. 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 LOSS OF OXYGEN THERAPY WAS SUSPECTED TO BE DUE TO A COMPONENT LEAK BUT THE CAUSE COULD NOT BE IDENTIFIED. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.