FDA Adverse Event
Malfunction
Summary report: N
MAXIMOVE (GLOUCESTER)
MDR report key: 3221152
·
Received July 5, 2013
Report
- Report Number
- 9611530-2013-00081
- 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). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO (B)(4). AS OF 06/15/2010, THAT NUMBER WAS DEACTIVATED DUE TO THE SITE NO LONGER BEING A MFR. COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO (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 |
|---|---|---|---|---|---|---|---|
| 307904 | MAXIMOVE (GLOUCESTER) | FSA | ARJO HOSPITAL EQUIPMENT AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |