MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-12 for IMRIS T2X OR TABLE V2 (ORT100) 110470-000 manufactured by Imris - Deerfield Imaging, Inc..
[97876641]
This table was manufactured in 2010 and had been in use for 8 years. An internal capa ((b)(4)) was initiated for drift observed in ort100 tables. The table in question was repaired using corrective and preventive actions implemented in the capa. The hydraulic fluid was flushed and the in-line filter was replaced. After the hydraulic fluid exchange was performed, an air bleed procedure was conducted. The table was then drift tested to verify proper function.
Patient Sequence No: 1, Text Type: N, H10
[97876642]
During a patient procedure, it was observed that the ort100 operating room table was drifting slightly to the right. The level of drift was observed via the catheter bag not being level. Or personnel re-leveled the table approximately every half hour during the procedure and were able to complete the procedure successfully. There were no injuries sustained by the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2018-00001 |
| MDR Report Key | 7188170 |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-12 |
| Date of Event | 2017-12-21 |
| Date Mfgr Received | 2017-12-21 |
| Device Manufacturer Date | 2010-02-15 |
| Date Added to Maude | 2018-01-12 |
| 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 T2X OR TABLE V2 (ORT100) |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | KXJ |
| Date Received | 2018-01-12 |
| Model Number | ORT100 |
| Catalog Number | 110470-000 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-01-12 |