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 2017-07-05 for ORT300 OPERATING ROOM TABLE 114093-000 manufactured by Imris-deerfield Imaging, Inc..
[79087418]
Based on a review of trending analysis of customer complaints and service calls, this incident appears to be an isolated incident. The device history record for the or table was reviewed and no discrepancies were observed. The field service engineer visited the customer site to inspect the table and perform further investigation into the root cause. The issue of drift was verified in the trendelenburg cylinder. A replacement trend cylinder was installed. The table was functionally tested to verify proper operation, including a 10 hour overnight drift test with 25 kg placed at the end of the back section. The drift test result passed with 0. 0 degrees of drift. The trendelenburg cylinder is being returned to imris and will subsequently be shipped to the vendor for further root cause investigation.
Patient Sequence No: 1, Text Type: N, H10
[79087419]
During a surgical procedure for cerebral arterial venus malformation (avm) on (b)(6) 2017, the chief nurse and the surgeons noticed that the patient was bleeding excessively and intracranial pressure had dropped. The surgeons elected to not perform intra-operative imaging due to the swollen cerebellum. They closed the skin quickly without properly closing the skull and the dura mater. As they were preparing the room for post-op imaging after the case, they observed that the or table was tilted head downward. Post-surgery (at home), the child had a cerebral spinal fluid leak and returned to the hospital for a prolonged stay. The cerebral spinal fluid leak recurred two more times because the dura mater and not been closed. The leaks were repaired with stitches on both occurrences. On (b)(6) 2017, the patient underwent a second operation to close the dura mater, skull and skin. The surgery went well according to the or staff. The impact on the patient's neurological functions are undeterminable at this point.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2017-00003 |
| MDR Report Key | 6687124 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-05 |
| Date of Report | 2017-05-11 |
| Date of Event | 2017-04-03 |
| Date Mfgr Received | 2017-04-13 |
| Device Manufacturer Date | 2016-05-19 |
| Date Added to Maude | 2017-07-05 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORT300 OPERATING ROOM TABLE |
| Generic Name | RADIOLOGIC TABLE, PRODUCT CODE: KXJ |
| Product Code | KXJ |
| Date Received | 2017-07-05 |
| Model Number | ORT300 |
| Catalog Number | 114093-000 |
| 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 | 1. Required No Informationntervention | 2017-07-05 |