ADU
Received Sep 27, 2016 · Event occurred Aug 29, 2016
Report 9610105-2016-00050 · MDR key 5979991
Device
Product problems
- Pressure Problem
- Device Operates Differently Than Expected
- Pressure Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem
THE HOSPITAL REPORTED THAT, THE UNIT HAS A FIXED AUTO PEEP OF 24CMH2O. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
DATE OF DEVICE MANUFACTURE YEAR IS 2002. THE MONTH OF MANUFACTURE WAS (B)(6). A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND A REVIEW OF THE LOGS. THERE WERE NO ALARMS LOGGED AND THE GE SERVICE REPRESENTATIVE WAS UNABLE TO REPRODUCE THE ISSUE WITH THE POSITIVE END EXPIATORY PRESSURE (PEEP). THE SYSTEM IS WORKING PER DESIGN.