FDA Adverse Event
Other
Summary report: N
FLOW METER, OXYGEN
MDR report key: 2897566
·
Received December 3, 2012
Report
- Report Number
- 2523148-2012-00004
- Event Type
- Other
- Date Received
- December 3, 2012
- Manufacturer
- PRECISION MEDICAL, INC.
- Product Code
- CCL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IN CONCLUSION THIS ERROR APPEARS NOT TO BE FAULT OF THE DEVICE, BUT OF THE CARE GIVER. THE IMMEDIATE SOLUTION WOULD BE TRAINING AND VIGILANCE, WITH LONG TERM, A STANDARD CORRECTION, TO THE AIR FLOW METERS AND CANNULAS, FORCED ACROSS THE INDUSTRY BY THE FDA AND THE COMPRESSED GAS ASSOCIATION.
Description of Event or Problem · 1
.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLOW METER, OXYGEN | CCL | PRECISION MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |