ADU
Received Apr 27, 2017 · Event occurred Mar 28, 2017
Report 9610105-2017-00028 · MDR key 6525484
Device
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
REPLACED MANUAL CIRCUIT (MANUAL BAG TUBE) AND THE MANUAL BAG (MANUAL BAG 2.0 L) TO FIX THE REPORTED ISSUE.
Additional Manufacturer Narrative
GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BLOCK A: NO REPORT OF PATIENT INVOLVEMENT. BLOCK E1: THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S. AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.
Description of Event or Problem
THE HOSPITAL REPORTED THAT, MANUAL VENTILATION IS NOT AVAILABLE DUE TO HIGH LEAK RATE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.