MalfunctionBSZ
ADU
Received Jul 19, 2019
Report 9610105-2019-00007 · MDR key 8807992
Device
Product problems
- Therapeutic or Diagnostic Output Failure
- Therapeutic or Diagnostic Output Failure
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 EVENTS. TO RESOLVE THE REPORTED ISSUE, THE BAG TO VENT MICROSWITCH WAS REPLACED.
Description of Event or Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL ADU-98 ANESTHESIA GAS MACHINE EXPERIENCED A MALFUNCTION CAUSING A LOSS OF MECHANICAL VENTILATION. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE REPORTED EVENT DID NOT INVOLVE A PATIENT.