FDA Adverse Event
Malfunction
Summary report: N
PRECISION MEDICAL
MDR report key: 1627422
·
Received March 8, 2010
Report
- Report Number
- 2523148-2010-00001
- Event Type
- Malfunction
- Date Received
- March 8, 2010
- Date of Event
- March 5, 2010
- Report Date
- March 5, 2010
- Manufacturer
- PRECISION MEDICAL, INC.
- Product Code
- BXY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL LOT #: 0110. FOUND THAT DEVICE IS MISLABELED ON TWO DIFFERENT LOTS 12/09 AND 01/10. DEVICE CAN APPEAR TO BE IN THE ON POSITION WHEN IT IS REALLY OFF.
Description of Event or Problem · 1
FLOW SELECTOR IS MISLABELED. SELECTOR CAN BE POSITIONED IN THE "ON" POSITION TO ADMINISTER OXYGEN AND REALLY BE IN THE "OFF" POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION MEDICAL | OXYGEN FLOW SELECTOR | BXY | PRECISION MEDICAL, INC. | PM1000 | 1209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |