FDA Adverse Event
Malfunction
Summary report: N
HIGH FLOW THERAPY MACHINE, O2FLO, EU VERSION
MDR report key: 10457087
·
Received August 26, 2020
Report
- Report Number
- 3012307300-2020-08524
- Event Type
- Malfunction
- Date Received
- August 26, 2020
- Date of Event
- July 29, 2020
- Report Date
- October 30, 2020
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 0
OTHER, OTHER TEXT: UNDER FURTHER ANALYSIS, THIS PRODUCT IS A PURCHASED FINISHED GOOD (PFG) AND DOES NOT NEED REPORTING BY SMITHS MEDICAL AS THIS IS NOT REPORTED UNDER FDA REGULATION. THE INITIAL REPORT WAS SENT IN ERROR.
Description of Event or Problem · 1
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MACHINE TO THE OXYGEN FLOW METER TUBE LINE KEPT DISCONNECTING WHEN THE FLOW WAS INCREASED TO ABOVE 20 LITER IN THE FLOWMETER. THERE WERE NO REPORTED ADVERSE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 922418 | HIGH FLOW THERAPY MACHINE, O2FLO, EU VERSION | GENERATOR, OXYGEN, PORTABLE | CAW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |