inforMED
MalfunctionBSZ

FABIUS GS PREMIUM

Received Oct 1, 2025 · Event occurred Apr 24, 2025

Report 23187763 · MDR key 23187763

Device

Generic name

Gas-machine, Anesthesia

Model number

980

Product problems

  • Loss of Power

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PRIOR TO SURGICAL TIMEOUT, THE ANESTHESIA MACHINE LOST POWER FOR APPROXIMATELY 10-15 MINUTES WITH THE PATIENT ALREADY INTUBATED AND POSITIONED IN BEACH CHAIR. PATIENT WAS PLACED ON PORTABLE MONITOR AND PORTABLE OXYGEN VIA AMBU BAG UNTIL THE MACHINE WAS RESET. ONCE MACHINE POWER WAS RESTORED, PATIENT WAS SAFELY TRANSFERRED BACK TO VENTILATOR. PER CLINICAL ENGINEERING ASSESSMENT, THEY COULD NOT REPRODUCE THE ¿DISCONNECT¿ ALARM AND THE VENTILATOR PASSED THE EST (EXTENDED SELF-TEST).