MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for IMRIS T2X OR TABLE V2 (ORT100) 110470-000 manufactured by Imris - Deerfield Imaging, Inc..
[92906679]
The drift issue was isolated by the service field engineer to the roll cylinder and the flow control valves. They were replaced, the hydraulic system was flushed and bled of any air, and two 8-hour drift tests were conducted to verify proper function of the table.
Patient Sequence No: 1, Text Type: N, H10
[92906680]
The customer stated that the ort100 table exhibited roll drift issues. It was later discovered that a patient had been involved in the incident when the drift in the roll cylinder was observed. The table was re-leveled by or staff and the procedure was completed successfully. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2017-00009 |
| MDR Report Key | 7026574 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-11-13 |
| Date of Event | 2017-10-02 |
| Date Mfgr Received | 2017-10-02 |
| Device Manufacturer Date | 2010-09-27 |
| Date Added to Maude | 2017-11-13 |
| 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 |
| 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 | 2017-11-13 |
| 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 | 2017-11-13 |