inforMED
MalfunctionBSZ

ADU

Received Apr 22, 2019

Report 9610105-2019-00004 · MDR key 8537066

Device

Generic name

Anesthesia Gas Machine

Model number

ADU-98

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.