FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 2000
MDR report key: 3201518
·
Received June 27, 2013
Report
- Report Number
- 9611530-2013-00068
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Report Date
- June 26, 2013
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- ILM
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MFR ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF THE IMPORTER (B)(4). ADD'L INFO 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 |
|---|---|---|---|---|---|---|---|
| 294337 | SYSTEM 2000 | ILM | ARJO HOSPITAL EQUIPMENT AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |