GIRAFFE IRS
Received May 19, 2026 · Event occurred Apr 21, 2026
Report 3036470679-2026-00065 · MDR key 25215505
Device
Product problems
- Gas/Air Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING PRE-USE CHECKOUT RESULTING IN A LEAK AND POTENTIAL LOSS OF OXYGEN THERAPY. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
GE HEALTHCARE¿S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. BLOCK D4 PRIMARY UDI NUMBER: THERE IS NO UDI AVAILABLE AS THE DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE REQUIREMENTS. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.
Additional Manufacturer Narrative
THE CUSTOMER DECLINED GE HEALTHCARE SERVICE. NO REPAIR INFORMATION AVAILABLE.