ADU
Received Sep 24, 2019 · Event occurred Jul 10, 2019
Report 9610105-2019-00008 · MDR key 9108819
Device
Product problems
- Increase in Pressure
- Increase in Pressure
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE EXPIRATION VALVE WAS REPLACED TO RESOLVE THE REPORTED ISSUE. PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. DATE RECEIVED BY MANUFACTURER: THIS MDR MALFUNCTION EVENT WAS PREVIOUSLY ELIGIBLE FOR THE VOLUNTARY MALFUNCTION SUMMARY REPORTING (VMSR) PROGRAM. AS OF 9/16/2019 NOTIFICATION FROM FDA, THIS PRODUCT CODE IS NO LONGER ELIGIBLE FOR VMSR. ACCORDING TO THE NOTIFICATION, GE HEALTHCARE MUST SUBMIT INDIVIDUAL REPORTS WITHIN 30 CALENDAR DAYS OF RECEIVING THE NOTIFICATION. THEREFORE, THIS EVENT IS BEING REPORTED AS AN INDIVIDUAL MDR REPORT DUE 10/16/2019.
Description of Event or Problem
THE HOSPITAL REPORTED EXCESSIVE PRESSURE IN THE PATIENT CIRCUIT. THERE WAS NO REPORT OF PATIENT INJURY.