MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-03-25 for IMRIS ORT300 OPERATING ROOM TABLE 114093-000 manufactured by Deerfield Imaging, Inc..
[139701929]
The field service engineer observed hydraulic fluid dripping from the hydraulic line that runs to the pressure gauge of the ort300 table. He replaced the or table hydraulic line that runs to the pressure gauge to resolve the issue.
Patient Sequence No: 1, Text Type: N, H10
[139701930]
The customer service engineer was on-site to repair an ort300 table trolley. While inspecting the ort300 table, he observed hydraulic fluid dripping from the belly cover of the table while operating the hydraulic pump. There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2019-00004 |
| MDR Report Key | 8447989 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-01 |
| Device Manufacturer Date | 2014-12-09 |
| Date Added to Maude | 2019-03-25 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMRIS ORT300 OPERATING ROOM TABLE |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | KXJ |
| Date Received | 2019-03-25 |
| Model Number | ORT300 |
| Catalog Number | 114093-000 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEERFIELD IMAGING, INC. |
| Manufacturer Address | 5101 SHADY OAK ROAD MINNETONKA MN 553434100 US 553434100 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-25 |