MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-11 for IMRIS T2X OR TABLE V2 (ORT100) 110470-000 manufactured by Imris - Deerfield Imaging, Inc..
[95080599]
The imris customer service engineer was on site on october 31, 2017 to diagnose the issue with the or table drifting in the roll position. He replaced the hydraulic manifold and performed a hydraulic fluid flush to clear any contaminants in the manifold. This did not resolve the issue. On (b)(6) hydraulic fluid flush and air bleed procedures were performed. This did not resolve the issue; therefore, the table was taken out of service until the drift issue was resolved. On (b)(6) a new hydraulic manifold was installed, tested the table, and found the manifold faulty. He installed a 2nd new manifold on (b)(6). The table was tested and did not pass the drift test. Internal capa (b)(4) has been issued to resolve the drift issue.
Patient Sequence No: 1, Text Type: N, H10
[95080600]
On (b)(6) 2017, during setup for a procedure and pre-positioning the patient on the operating room (or) table, it was noticed that the or table was drifting slightly in the roll position. The procedure was moved to a different or suite. The patient did not sustain any injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2017-00014 |
| MDR Report Key | 7103864 |
| Date Received | 2017-12-11 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-10-30 |
| Date Mfgr Received | 2017-10-30 |
| Device Manufacturer Date | 2010-10-17 |
| Date Added to Maude | 2017-12-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SANJAY SHAH |
| Manufacturer Street | 5101 SHADY OAK ROAD |
| Manufacturer City | MINNETONKA MN 553434100 |
| Manufacturer Country | US |
| Manufacturer Postal | 553434100 |
| Manufacturer Phone | 7632036380 |
| Manufacturer G1 | IMRIS - DEERFIELD IMAGING, INC. |
| Manufacturer Street | 5101 SHADY OAK ROAD |
| Manufacturer City | MINNETONKA MN 553434100 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 553434100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMRIS T2X OR TABLE V2 (ORT100) |
| Generic Name | OPERATING ROOM TABLE, PRODUCT CODE: KXJ |
| Product Code | KXJ |
| Date Received | 2017-12-11 |
| Model Number | ORT100 |
| Catalog Number | 110470-000 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMRIS - DEERFIELD IMAGING, INC. |
| Manufacturer Address | 5101 SHADY OAK ROAD MINNETONKA MN 553434100 US 553434100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-11 |