MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-05 for IMRIS ORT100 OPERATING ROOM TABLE ORT100 (T2) 108000-000 manufactured by Imris - Deerfield Imaging, Inc..
[99198386]
The table rotational lock was not working as a result of loose tension on the foot pedal. The tension was re-adjusted and the rotational lock was tested to verify proper function. Internal capa issued.
Patient Sequence No: 1, Text Type: N, H10
[99198387]
The customer stated that the ort100 table is not locking because the foot pedal does not work. On (b)(6) 2017, the customer stated that the table can unlock if it is shaken vigorously. These incidents were observed during routine qa - no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2018-00017 |
| MDR Report Key | 7243079 |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-05 |
| Date of Event | 2017-09-18 |
| Date Mfgr Received | 2017-12-20 |
| Device Manufacturer Date | 2007-10-11 |
| Date Added to Maude | 2018-02-05 |
| 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 | 2018-02-05 |
| Model Number | ORT100 (T2) |
| Catalog Number | 108000-000 |
| 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 | 2018-02-05 |