MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-17 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim.
[97974152]
Locks up during scan;error log "system log file full". Customer states cannot proceed even after restart. Customer is stating the system was not able to produce fluoro during the case. This is unknown why but the biomed cody stated the systems were completely shutdown and rebooted which he was unable to reproduce the issue. The customer also indicated the sedecal console displayed a log file is full which made them think there was an issue. This is not an issue that will inhibit the system from functioning. Provided the customer with the procedure to clear the log files. Then requested the customer to attempt to fluoro which he was unable to do. It was then determined this would not occur due to a patient file not being open. They were not in acquire mode.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2017-00032 |
| MDR Report Key | 7198960 |
| Date Received | 2018-01-17 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-12-27 |
| Date Mfgr Received | 2017-12-21 |
| Device Manufacturer Date | 2008-01-31 |
| Date Added to Maude | 2018-01-17 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FRED RECKELHOFF |
| Manufacturer Street | 2111 E. GALBRAITH RD |
| 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-REVERSE |
| Generic Name | HUT EXT DR FINAL ASSY-REVERSE |
| Product Code | IXR |
| Date Received | 2018-01-17 |
| Model Number | 404007 |
| 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 RD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-17 |