GIRAFFE IRS
Received Jul 24, 2024 · Event occurred Jun 25, 2024
Report 2112667-2024-03940 · MDR key 19823645
Device
Generic name
Ventilator, Emergency, Manual
Manufacturer
Datex-ohmeda, Inc.Product problems
- Mechanical Problem
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE CHECK VALVE ASSEMBLY WAS REPLACED TO RESOLVE THE ISSUE. D4 PRIMARY UDI NUMBER: NO UDI AVAILABLE AS DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE.
Additional Manufacturer Narrative
A GE HEALTHCARE INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. NO REPAIR INFORMATION AVAILABLE. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN CHECK VALVE FAILURE CAUSING OXYGEN LEAK. THERE WAS NO PATIENT INVOLVEMENT.