FDA Adverse Event
Other
Summary report: N
IMRIS NEURO II-SE (OR-DR-OR) ORT100
MDR report key: 1960281
·
Received December 9, 2010
Report
- Report Number
- 3003807210-2010-00005
- Event Type
- Other
- Date Received
- December 9, 2010
- Date of Event
- November 12, 2010
- Report Date
- December 10, 2010
- Manufacturer
- IMRIS, INC.
- Product Code
- LNH
- PMA / PMN Number
- K050132
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE OPERATING ROOM TABLE PENDANT WILL BE RETURNED TO IMRIS FOR EVAL. A F/U REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE DEVICE COMPONENT EVAL.
Description of Event or Problem · 1
ON (B)(6) 2010, AN IMRIS CUSTOMER SUPPORT SPECIALIST REPORTED THAT THE OPERATING ROOM TABLE MOVED TO THE MAXIMUM HEIGHT OR TILT CONTINUOUSLY UPON TURNING ON THE OPERATING ROOM TABLE PENDANT (CONTROLLER). THERE WERE NO REPORTS OF INJURY TO THE PATIENT OR CLINICAL STAFF. INITIAL INSPECTION OF THE OPERATING ROOM TABLE DETERMINED THAT THE ISSUE COULD BE ATTRIBUTED TO THE OPERATING ROOM PENDANT SINCE THE REPLACEMENT OF THE PENDANT RESULTED IN A CORRECTION OF THE PROBLEM. A REPLACEMENT PENDANT HAS BEEN SHIPPED TO THE SITE PENDING THE RETURN AND EVAL OF THE ORIGINAL DEVICE COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMRIS NEURO II-SE (OR-DR-OR) ORT100 | MAGNETIC RES. IMAGING SYSTEM OPERATING ROOM TABLE | LNH | IMRIS, INC. | 108000-000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other | NO |