FDA Adverse Event
Malfunction
Summary report: N
AIRLIFE OXYGEN TUBING
MDR report key: 22436546
·
Received July 8, 2025
Report
- Report Number
- 22436546
- Event Type
- Malfunction
- Date Received
- July 8, 2025
- Date of Event
- June 17, 2025
- Report Date
- June 30, 2025
- Manufacturer
- AIRLIFE FINLAND OY
- Product Code
- BYX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT HAD OXYGEN TUBING FROM VENTILATOR TO FLOWMETER. UPON TRYING TO SWITCH OVER OXYGEN TUBING TO OXYGEN TANK FOR TRANSPORT, O2 TUBING WOULD NOT COME OFF OF FLOWMETER. AFTER TRYING TO PULL TUBING OFF, IT RIPPED. RT [RESPIRATORY THERAPIST] HAD TO QUICKLY FIND REPLACEMENT FLOWMETER AND TUBING SO PATIENT COULD BE SAFETY REATTACHED TO OXYGEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387582 | AIRLIFE OXYGEN TUBING | TUBING, PRESSURE AND ACCESSORIES | BYX | AIRLIFE FINLAND OY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 MO | Male |