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 2018-09-07 for IMRIS ORT100 OPERATING ROOM TABLE 110470-000 manufactured by Deerfield Imaging, Inc..
[119499737]
The ort100 table has not yet been evaluated. A follow-up report will be submitted once root cause has been established.
Patient Sequence No: 1, Text Type: N, H10
[119499738]
The customer stated that the ort100 table stopped moving during daily testing. They observed hydraulic fluid in the control panel of the table. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2018-00037 |
| MDR Report Key | 7854812 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-07 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2010-06-22 |
| Date Added to Maude | 2018-09-07 |
| 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 | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMRIS ORT100 OPERATING ROOM TABLE |
| Generic Name | OPERATING ROOM TABLE |
| Product Code | KXJ |
| Date Received | 2018-09-07 |
| Model Number | ORT100 |
| Catalog Number | 110470-000 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-09-07 |