inforMED
MalfunctionBSZ

ADU

Received Jul 19, 2019

Report 9610105-2019-00005 · MDR key 8807603

Device

Generic name

Anesthesia Gas Machine

Model number

ADU-98

Product problems

  • Mechanical Problem
  • Gas/Air Leak
  • Mechanical Problem
  • Gas/Air Leak

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

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 COMPACT BLOCK 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 RESULTING IN A LEAK CAUSING A COMPLETE LOSS OF ALL VENTILATION MODES. THE REPORTED EVENT DID NOT INVOLVE A PATIENT.