ADU
Received May 10, 2017 · Event occurred Apr 10, 2017
Report 9610105-2017-00034 · MDR key 6556391
Device
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE FAILURE IN THIS CASE WAS DUE TO ANOTHER MANUFACTURER'S PRODUCT. THEREFORE, THE INITIAL MDR WAS NOT REPORTABLE.
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. 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. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem
THE HOSPITAL REPORTED THAT THE UNIT FAILED THE LEAK TEST AND THE LEAK RATE WAS UNKNOWN. THERE WAS NO REPORTED PATIENT INVOLVEMENT.