FDA Adverse Event
Malfunction
Summary report: N
MAXI MOVE
MDR report key: 3251910
·
Received July 22, 2013
Report
- Report Number
- 9611530-2013-00087
- Event Type
- Malfunction
- Date Received
- July 22, 2013
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MFR ARJO (B)(4) ON BEHALF OF THE IMPORTER (B)(4). THE WAS INSPECTED ON-SITE BY A REP OF THE MFR'S SALES AND SVC UNIT SUBSIDIARY DIV, NOT A DIRECT EMPLOYEE OF THE MFR. ADD'L INFO WILL BE PROVIDED UPON COMPLETION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340579 | MAXI MOVE | FSA | ARJO HOSPITAL EQUIPMENT AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |