MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-20 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim.
[121567969]
Biomed called service reporting that with a patient on the table, they had a system message saying `align system chain needed'. The biomed had tried pressing the `imaging chain' key, but system would not automatically re-align. The hut system safety interlock will not allow fluoro if the proper alignment isn't achieved. Tech support helped biomed troubleshoot and also found that normal table movement was lost because the users had moved table splash/crash cover into an object. Biomed physically moved the cover to release the limit switches and all table movements were restored except for the image chain alignment. Patient was then moved to complete the procedure. When biomed called back to service, he reported that he had troubleshot the alignment issue to a corroded transducer. Amplifier board under the table. The biomed had replaced the transducer amplifier board and the system was fully functional. Tech support asked biomed where he got the replacement board, and he indicated he got it through his central ordering service. Tech support checked and was not able to find that it was purchased through guerbet service. A review of cts shows a similar table misalignment issue reported on this unit in 2013. This is a known issue, reference ci-capa-(b)(4), in which `no fluoro 'tube carriage and no table movement issues were identified as complaint trends where the most common part identified with the issue was pn 400813 pcba. No further investigation needed at this time. Qa will continue to monitor and trend for similar issues. These trends and issues are reported on during quality metrics reviews and during the management review meetings.
Patient Sequence No: 1, Text Type: N, H10
[121567970]
Initial complaint received on (b)(6) 2018. Reporter notified guerbet of mechanical failure - alignment. Reporter states that the align image chain needed to be performed, and that the patient is on the table. Reporter attempted to realign the image chain but it would not automatically align when pressing the imaging chain key. Reporter indicated the users have crashed the splash/crash guard into an object. This is known because he had to move the guard to release the limit switches. All the table movements were then restored except for the image chain alignment. The patient had to then be moved because the image chain would not realign due to this operator error. Report receiver received an update on 27 august 2018 in which a transducer amplifier was found to be corroded for the image intensifier. The customer ordered and replace the transducer amplifier, p/n 400813. The system is now fully functional. This would be a sign that a leak occurred in the table which affected the board causing malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2018-00034 |
| MDR Report Key | 7894097 |
| Date Received | 2018-09-20 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-08-22 |
| Date Mfgr Received | 2018-08-22 |
| Device Manufacturer Date | 2018-02-28 |
| Date Added to Maude | 2018-09-20 |
| 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 | FRED RECKELHOFF |
| Manufacturer Street | 2111 E GALBRAITH ROAD |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HUT EXT DR FINAL ASSY-STANDARD |
| Generic Name | HUT EXT DR FINAL ASSY-STANDARD |
| Product Code | IXR |
| Date Received | 2018-09-20 |
| Model Number | 404008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E GALBRAITH ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-20 |