MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-21 for T2X OPERATING ROOM TABLE 109682-000 manufactured by Imris - Deerfield Imaging, Inc..
[83531145]
The imris field service engineer met with personnel from clinical engineering to inspect the or table. They concluded that the back section was not fully seated and locked into the table at the time when the incident occurred. They fully tested table movement and back section locking mechanism to ensure proper operation. All testing passed. Imris clinical education team shall communicate with (b)(6) operating room (o. R. ) personnel to ensure that they are following the instructions in the ifu and to re-educate cleaning crew and clinical staff that prepares the operating room (o. R. ) for proper usage of the or table back section. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[83531146]
At approximately 2 pm on (b)(6) 2017, the back section detached from the t2x or table with a patient during preparation for a surgery. The back section dropped to the floor and the patient slid off the back section to the floor. The patient was immediately brought to mr and imaged. No injuries were found during imaging. The following day, hospital staff confirmed that there were no injuries suffered by the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2017-00008 |
| MDR Report Key | 6808034 |
| Date Received | 2017-08-21 |
| Date of Report | 2017-10-20 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2017-08-15 |
| Date Added to Maude | 2017-08-21 |
| 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. SANJAY SHAH |
| Manufacturer Street | 5101 SHADY OAK ROAD |
| Manufacturer City | MINNETONKA MN 553434100 |
| Manufacturer Country | US |
| Manufacturer Postal | 553434100 |
| Manufacturer Phone | 7632036380 |
| 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 | T2X OPERATING ROOM TABLE |
| Generic Name | RADIOLOGIC TABLE, PRODUCT CODE: KXJ |
| Product Code | KXJ |
| Date Received | 2017-08-21 |
| Model Number | T2X |
| Catalog Number | 109682-000 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-08-21 |