inforMED
MalfunctionBSZ

ADU

Received Jul 19, 2019

Report 9610105-2019-00006 · MDR key 8807953

Device

Generic name

Anesthesia Gas Machine

Model number

ADU-98

Product problems

  • Mechanical Problem
  • Infusion or Flow Problem
  • Mechanical Problem
  • Infusion or Flow 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 EVENTS. TO RESOLVE THE REPORTED ISSUE, THE ADJUSTABLE PRESSURE LIMIT VALVE 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 OF THE ADJUSTABLE PRESSURE LIMIT VALVE PREVENTING MANUAL VENTILATION. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE REPORTED EVENT DID NOT INVOLVE A PATIENT.