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 110470-600 manufactured by Imris - Deerfield Imaging, Inc..
[99198857]
The table continues to be used with the stabilizing bracket for the rotational locking mechanism. New parts shall be installed. Internal capa issued.
Patient Sequence No: 1, Text Type: N, H10
[99198858]
The rotational locking mechanism in the ort100 table was observed to be functioning incorrectly. It would not remain locked. The rotation function of the table was temporarily locked in place using a metal bracket so the table could continue to be used for procedures. With the table in the locked position, there was no risk of unintended motion to the patients that underwent surgical procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2018-00006 |
| MDR Report Key | 7243078 |
| Date Received | 2018-02-05 |
| Date of Report | 2018-02-05 |
| Date of Event | 2017-08-07 |
| Date Mfgr Received | 2017-08-07 |
| Device Manufacturer Date | 2010-06-01 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 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 |
| Catalog Number | 110470-600 |
| Lot Number | N/A |
| Operator | PHYSICIAN |
| 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 |