MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-15 for IMRIS T@X OR TABLE V2 (ORT100) 110470-000 manufactured by Imris-deerfield Imaging, Inc..
[95913912]
The ort100 table is in the process of being evaluated. A follow-up report shall be submitted to fda when the evaluation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[95913913]
On (b)(6) 2017, it was reported that, 3-4 hours into an awake craniotomy procedure, the surgeon noticed that the patient was not flat. The ort100 operating room table had drifted slightly to the right side. They counterbalanced the table in order to proceed. The procedure was completed successfully. There were no injuries sustained by the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2017-00013 |
| MDR Report Key | 7123452 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-15 |
| Date of Report | 2018-07-14 |
| Date of Event | 2017-11-28 |
| Date Mfgr Received | 2017-11-29 |
| Device Manufacturer Date | 2011-04-21 |
| Date Added to Maude | 2017-12-15 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TODD SPERLING |
| Manufacturer Street | 5101 SHADY OAK ROAD |
| Manufacturer City | MINNETONKA MN 553434100 |
| Manufacturer Country | US |
| Manufacturer Postal | 553434100 |
| Manufacturer Phone | 7632036344 |
| 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 T@X OR TABLE V2 (ORT100) |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | KXJ |
| Date Received | 2017-12-15 |
| Model Number | ORT100 |
| Catalog Number | 110470-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-12-15 |