MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-29 for IMRIS ORT100 OPERATING ROOM TABLE 110470-000 manufactured by Imris - Deerfield Imaging, Inc..
[104139506]
The service engineer observed that the roll cylinder exhibited leakage through the valve seals. The roll cylinder was replaced, as were the check valves and o-ring. The table was tested to verify proper function.
Patient Sequence No: 1, Text Type: N, H10
[104139507]
The customer service engineer stated that the roll cylinder on the ort100 table drifted over a six hour period. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2018-00033 |
| MDR Report Key | 7381254 |
| Date Received | 2018-03-29 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-03-03 |
| Date Mfgr Received | 2018-03-03 |
| Device Manufacturer Date | 2011-04-21 |
| Date Added to Maude | 2018-03-29 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| 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 | 2018-03-29 |
| Model Number | ORT100 |
| Catalog Number | 110470-000 |
| Lot Number | N/A |
| Operator | SERVICE PERSONNEL |
| 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 | 2018-03-29 |