Intelli-OX+ Medical Oxygen Cylinder
Received Jul 22, 2026 · Event occurred May 16, 2026
Report 25904140 · MDR key 25904140
Device
Product problems
- Device Alarm System
- Use of Device Problem
- Improper or Incorrect Procedure or Method
- Insufficient Device Problem Information
Patient
Not reported
- Hypoxia
- Loss of consciousness
- Insufficient Information
Narrative
Description of Event or Problem
ON "[REDACTED]", A PATIENT REQUIRING CONTINUOUS OXYGEN THERAPY WAS TRANSPORTED TO AND FROM CT ON A PORTABLE OXYGEN TANK. SHORTLY AFTER RETURNING TO THE UNIT, THE PATIENT WAS FOUND UNRESPONSIVE AND HYPOXIC DURING ROUTINE PHYSICIAN ROUNDS. THE PATIENT REQUIRED EMERGENCY INTERVENTION, INCLUDING NON-REBREATHER OXYGEN, BIPAP SUPPORT, AND TRANSFER TO THE ICU. EVALUATION OF THE PORTABLE OXYGEN TANK AFTER THE EVENT REVEALED IT WAS EMPTY, ALTHOUGH IT IS UNCLEAR WHEN THE OXYGEN SUPPLY BECAME DEPLETED. WHAT MALFUNCTIONED OR MADE IT DIFFICULT TO USE? THE PORTABLE OXYGEN TANK WAS EMPTY AT THE TIME OF EVALUATION, AND THE INVESTIGATION IDENTIFIED POTENTIAL EQUIPMENT AND PROCESS ISSUES, INCLUDING THE LACK OF EFFECTIVE LOW-PRESSURE OR EMPTY-TANK ALARMS, ABSENCE OF RELIABLE OXYGEN DEPLETION MONITORING. THERE WAS ALSO A PROCESS GAP IN STAFF VERIFYING OXYGEN TANK VOLUME BEFORE AND AFTER TRANSPORT. THESE FACTORS MADE IT DIFFICULT TO RECOGNIZE THAT THE PATIENT WAS NO LONGER RECEIVING OXYGEN.
Description of Event or Problem
On "[redacted]", a patient requiring continuous oxygen therapy was transported to and from CT on a portable oxygen tank. Shortly after returning to the unit, the patient was found unresponsive and hypoxic during routine physician rounds. The patient required emergency intervention, including non-rebreather oxygen, BiPAP support, and transfer to the ICU. Evaluation of the portable oxygen tank after the event revealed it was empty, although it is unclear when the oxygen supply became depleted.What malfunctioned or made it difficult to use?The portable oxygen tank was empty at the time of evaluation, and the investigation identified potential equipment and process issues, including the lack of effective low-pressure or empty-tank alarms, absence of reliable oxygen depletion monitoring. There was also a process gap in staff verifying oxygen tank volume before and after transport. These factors made it difficult to recognize that the patient was no longer receiving oxygen.