inforMED
MalfunctionCAN

MEDIVITOP

Received May 16, 2025 · Event occurred Feb 1, 2025

Report 3003207908-2025-00001 · MDR key 22035204

Device

Generic name

Vipr

Manufacturer

Gce, S.r.o.

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

MIDLANDS AIR AMBULANCE CHARITY REPORTED TO MHRA - MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY, UNITED KINGDOM: PATIENT WAS ANAESTHETISED, VENTILATED AND TRANSPORTED TO HOSPITAL BY AIR. THE FLIGHT WAS APPROXIMATELY 20 MINUTES. PRIOR TO TAKE OFF THE CYLINDER WAS CHANGED TO A FULL ONE, THEREFORE, THE QUANTITY OF OXYGEN AVAILABLE IN THE CYLINDER SHOULD HAVE SUFFICIENT. ON ARRIVAL AT HOSPITAL AND WHEN TRANSFERRING THE PATIENT FROM THE AIRCRAFT TO THE RESUSROOM (APPROX 30 METRES) THE VENTILATOR ALARMED AND THE CYLINDER WAS IDENTIFIED AS EMPTY.

Description of Event or Problem

(B)(6) REPORTED TO MHRA - MEDICINES & HEALTHCARE PRODUCTS REGULATORY AGENCY, UNITED KINGDOM: PATIENT WAS ANAESTHETISED, VENTILATED AND TRANSPORTED TO HOSPITAL BY AIR. THE FLIGHT WAS APPROXIMATELY 20 MINUTES. PRIOR TO TAKE OFF THE CYLINDER WAS CHANGED TO A FULL ONE, THEREFORE THE QUANTITY OF OXYGEN AVAILABLE IN THE CYLINDER SHOULD HAVE SUFFICIENT. ON ARRIVAL AT HOSPITAL AND WHEN TRANSFERRING THE PATIENT FROM THE AIRCRAFT TO THE RESUSROOM (APPROX 30 METRES) THE VENTILATOR ALARMED AND THE CYLINDER WAS IDENTIFIED AS EMPTY.

Remedial action

  • Modification/Adjustment