FDA Adverse Event
Malfunction
Summary report: N
MAXI MOVE
MDR report key: 3221094
·
Received July 5, 2013
Report
- Report Number
- 9611530-2013-00072
- Event Type
- Malfunction
- Date Received
- July 5, 2013
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MFR, ARJO (B)(4), ON BEHALF OF THE IMPORTER, (B)(4). THE DEVICE WAS INSPECTED ON SITE BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR';S INVESTIGATION.
Description of Event or Problem · 1
REF IMP REPORT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307576 | MAXI MOVE | FSA | ARJO HOSPITAL EQUIPMENT AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |