MalfunctionBSZ
ADU
Received Apr 22, 2019
Report 9610105-2019-00004 · MDR key 8537066
Device
Product problems
- Gas/Air Leak
- Gas/Air Leak
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
FOR THE REPORTED EVENT, THE HOSPITAL DECLINED GE HEALTHCARE SERVICE REPRESENTATIVE TROUBLESHOOTING. NO RESOLUTION INFORMATION IS AVAILABLE.
Description of Event or Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL ADU-98 ANESTHESIA GAS MACHINE FAILED A LEAK TEST RESULTING IN LOSS OF MECHANICAL VENTILATION. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE REPORTED EVENT DID NOT INVOLVE A PATIENT.