inforMED
MalfunctionBSZ

ADU

Received Jul 19, 2019

Report 9610105-2019-00007 · MDR key 8807992

Device

Generic name

Anesthesia Gas Machine

Model number

ADU-98

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.