MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-28 for IMRIS ORT100 OPERATING ROOM TABLE 110470-000 manufactured by Imris - Deerfield Imaging, Inc..
[103948883]
The service engineer performed a hydraulic fluid flush of the table and replaced the roll cylinder. An air bleed procedure was conducted and the table was tested to verify proper function.
Patient Sequence No: 1, Text Type: N, H10
[103948884]
The patient was on the ort100 table with a slight tilt placed on the table. The table began to drift and continued to drift during the procedure. Anti-tilt support bars that are used on the skytron or bed were utilized by attaching to the side rails of the ort100 table. The procedure was completed successfully. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2018-00032 |
| MDR Report Key | 7377342 |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2010-09-27 |
| Date Added to Maude | 2018-03-28 |
| 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 ORT100 OPERATING ROOM TABLE |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | KXJ |
| Date Received | 2018-03-28 |
| Model Number | ORT100 |
| Catalog Number | 110470-000 |
| Lot Number | N/A |
| Operator | NURSE |
| Device Availability | Y |
| 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 | 2018-03-28 |