GIRAFFE IRS
Received Feb 19, 2026 · Event occurred Jan 21, 2026
Report 3036470679-2026-00007 · MDR key 24389014
Device
Product problems
- Insufficient Flow or Under Infusion
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED MALFUNCTION WOULD NOT AFFECT OXYGEN THERAPY FUNCTION. THEREFORE, THERE WAS NO REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN SIGNIFICANT DEGRADATION OR LOSS OF OXYGEN THERAPY DURING PRE-USE CHECKOUT. 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. LEGAL MANUFACTURER: GEHC TROUT - 3114 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188.