MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-15 for IMRIS ORT300 OPERATING ROOM TABLE 114093-000 manufactured by Imris - Deerfield Imaging, Inc..
[93207102]
The field service engineer investigated this incident on october 27, 2017. He inspected the table and tested it for drift. He was unable to verify the drift symptoms. After he removed the covers of the table, he observed some small hydraulic fluid leakage from the manifold area. This could potentially be the underlying cause of the drift. The field service engineer will be replacing the leaking hydraulic component(s) and performing functional testing to verify proper operation after the repair has been completed.
Patient Sequence No: 1, Text Type: N, H10
[93207103]
The procedure had been successfully performed and mr imaging was completed. Hospital personnel were moving the magnet away from the table when they noticed contact between the head fixation device, which was attached to the table, and the bore of the magnet. This contact was not evident when the magnet was initially moved over the table and they assumed that the table drifted slightly downward. They lifted up on the back section of the table a small amount to eliminate the contact and then continued moving the magnet away from the table. There was no report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2017-00011 |
| MDR Report Key | 7034961 |
| Date Received | 2017-11-15 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-10-12 |
| Date Mfgr Received | 2017-10-12 |
| Device Manufacturer Date | 2016-02-18 |
| Date Added to Maude | 2017-11-15 |
| 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 |
| 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 ORT300 OPERATING ROOM TABLE |
| Generic Name | RADIOLOGIC TABLE |
| Product Code | KXJ |
| Date Received | 2017-11-15 |
| Model Number | ORT300 |
| Catalog Number | 114093-000 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-11-15 |