FDA Adverse Event
Malfunction
Summary report: N
NIMBUS 3/DFS3
MDR report key: 3319697
·
Received August 23, 2013
Report
- Report Number
- 1000381138-2013-00004
- Event Type
- Malfunction
- Date Received
- August 23, 2013
- Manufacturer
- HUNTLEIGH HEALTHCARE LTD.
- Product Code
- FNM
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MFR (ARJO (B)(4)). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 413627 | NIMBUS 3/DFS3 | FNM | HUNTLEIGH HEALTHCARE LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |