MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-07-13 for ORT300 OPERATING ROOM TABLE 114093-000 manufactured by Imris-deerfield Imaging, Inc..
[80009438]
The ort300 table in question was evaluated by the imris-deerfield imaging field service engineer. A small hydraulic fluid leak was observed. While at (b)(6), the field engineer inspected the hydraulic system, cylinders, manifold, and fittings but was unable to determine the exact location of the leak. The table is being returned to imris for further evaluation. When the root cause has been identified, imris shall send a follow-up report. The ort300 table was replaced with a new table on july 10, 2017.
Patient Sequence No: 1, Text Type: N, H10
[80009439]
On (b)(6) 2017, a (b)(6) year old patient was undergoing a cranial procedure. The procedure began at approximately 8:30 am. Around 5 pm, the anesthetist noticed that the ort300 table was lower and that the trendelenburg was not horizontal but tilted downwards towards the patient's head. The surgeon asked if someone had modified the table's position because it was too low. The surgical team then noticed that the table was not in its starting position. They repositioned the table and were able to film the table's descent. The surgery was continued in a non-optimal position for the patient because the table could not keep its position. Approximately at 9:30 pm, the team from imaging began to prepare the patient for mri. They did not see the table change orientation during the 30 minute scan. The patient experienced excessive bleeding from the head. There were no additional physiological consequences experienced by the patient.
Patient Sequence No: 1, Text Type: D, B5
[113535182]
This is a follow-up report. A summary of the root cause analysis follows. The ort300 table was evaluated upon return. Included was a picture of an oil leak and a video from the hospital. The video shows irregular motion when the table is actuated. The lift cylinder appears to be actuated. The table lifts as expected, however, when the actuation is completed, the table appears to relax to a lower position (drops in elevation). Based on the video, initial judgement to explain the issue is air trapped in the hydraulic system. This would cause a momentary instability of the table top position until the air bleeds over the hydraulic cylinder seal until the cylinder piston is supported by the hydraulic oil. An increased probability of trapped air in the hydraulic system is likely since the table had recently undergone a field repair that replaced two hydraulic cylinders. It appears that the field engineer did not completely bleed the air out of the system. When the table was returned, the behavior in the video could not be duplicated. It was concluded that any air trapped in the hydraulic system worked its way out of the system prior to return from the customer. In addition, a small oil leak was identified on the lower fittings of the trendelenburg cylinder. A small drift was present in the trendelenburg motion that appears to correspond with the leak. The drift rate of the table was tested multiple times and tested within specification.
Patient Sequence No: 1, Text Type: N, H10
[113535183]
On (b)(6) 2017, a (b)(6) patient was undergoing a cranial procedure. Later in the procedure, the anesthetist noticed that the table was lower and that the trendelenburg was not horizontal but tilted downwards towards the patient's head. The surgical team then noticed that the table was not in its starting position. They repositioned the table and were able to fild the table's descent. The surgery was continued in a non-optimal position for the patient because the table could not keep its position. The patient experienced excessive bleeding from his head. There were no additional physiological consequences experienced by the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010326005-2017-00006 |
| MDR Report Key | 6711785 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-13 |
| Date of Report | 2017-08-21 |
| Date of Event | 2017-06-12 |
| Date Mfgr Received | 2017-06-13 |
| Device Manufacturer Date | 2016-05-19 |
| Date Added to Maude | 2017-07-13 |
| 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 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 | RL |
| 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 | 2017-07-13 |
| Returned To Mfg | 2017-07-21 |
| Model Number | ORT300 |
| Catalog Number | 114093-000 |
| Lot Number | N/A |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| 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. Hospitalization; 2. Life Threatening | 2017-07-13 |