MalfunctionBSZ
ADU
Received Apr 22, 2019
Report 9610105-2019-00002 · MDR key 8536737
Device
Product problems
- Energy Output Problem
- Energy Output Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
FOR THE REPORTED EVENT, A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED EVENT. REPAIR WAS NOT POSSIBLE AS THE DEFECTIVE PART IS NO LONGER AVAILABLE. THE CUSTOMER WAS ADVISED.
Description of Event or Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL ADU-98 ANESTHESIA GAS MACHINE STOPPED WITH A MESSAGE ON THE LEFT-HAND MONITOR STATING THAT THE VENTILATOR IS FAULTY. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE REPORTED EVENT DID NOT INVOLVE A PATIENT.