GIRAFFE INCUBATOR

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED THAT THE ISSUE WAS AN OXYGEN CALIBRATION FAILURE OBSERVED PRIOR TO PATIENT USE. THIS ISSUE WOULD NOT RESULT IN OXYGEN FAILURE.

Additional Manufacturer Narrative

GE HEALTHCARE 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. 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.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN OXYGEN FAILURE. THERE WAS NO PATIENT INVOLVEMENT.