FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 2000
MDR report key: 3234033
·
Received July 11, 2013
Report
- Report Number
- 9611530-2013-00082
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- ILM
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MFR ARJOH (B)(4) ON BEHALF OF THE IMPORTER (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE 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 |
|---|---|---|---|---|---|---|---|
| 320704 | SYSTEM 2000 | ILM | ARJO HOSPITAL EQUIPMENT AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |