MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-15 for IMRIS ORT300 OPERATING ROOM TABLE 114093-600 manufactured by Imris - Deerfield Imaging, Inc..
[93119837]
(b)(4) 2017: the hospital's biomedical engineer performed table lift drift testing with a 40 kg load over night - no drift was observed. 11/1/2017: imris technologist inspected the table and performed trend and tilt drift test in the bore of the magnet for 45 minutes. No drift was observed. Imris clinical applications specialists and (b)(4) biomedical engineering performed table tilt drift testing twice in the bore of the magnet for 53 minutes. No drift was observed. 11/2 - 11/7/2017: imris r&d engineering performed 6 and 14-hour unloaded tilt drift testing, 6 and 14-hour 40 kg loaded tilt drift testing, 6-hour 200 kg loaded lift/tilt drift testing, and inspection of hydraulic lines after each drift test. After exhaustive testing, it was determined that the table is mechanically solid with no drift in the lift/trend/roll cylinders, but the back section is drifting, specifically during the first 60 minutes.
Patient Sequence No: 1, Text Type: N, H10
[93119838]
On (b)(6) 2017, the clinical staff prepared a six year old patient for intra-operative imaging and brought in the magnet over the patient. They imaged the patient for 45 minutes. After imaging, while retracting the magnet from over the patient, they heard a "clunk" and the table back section visibly dropped/moved. They returned the magnet to the home position. No injuries were sustained by the patient and mr images were reported to be good. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2017-00012 |
| MDR Report Key | 7035603 |
| Date Received | 2017-11-15 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-10-30 |
| Date Mfgr Received | 2017-10-31 |
| Device Manufacturer Date | 2016-05-19 |
| Date Added to Maude | 2017-11-15 |
| 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 | IMRIS ORT300 OPERATING ROOM TABLE |
| Generic Name | RADIOLOGIC TABLE |
| Product Code | KXJ |
| Date Received | 2017-11-15 |
| Model Number | ORT300 |
| Catalog Number | 114093-600 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-11-15 |