FDA Adverse Event
Malfunction
Summary report: N
OMNI-FLOW MODEL 4000 PLUS
MDR report key: 1231101
·
Received October 30, 2008
Report
- Report Number
- 2921482-2008-00344
- Event Type
- Malfunction
- Date Received
- October 30, 2008
- Date of Event
- October 15, 2008
- Report Date
- October 13, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K882594
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE EVENT THAT IS BEING REPORTED WAS NOTED DURING VERIFICATION TESTING; THEREFORE, USER FACILITY EVENT CODES ARE NOT APPLICABLE IN THIS CASE.
Description of Event or Problem · 1
DURING VERIFICATION TESTING AT THE MANUFACTURING FACILITY, UNRESTRICTED FLOW WAS NOTED ON LINE A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNI-FLOW MODEL 4000 PLUS | 80-FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |