MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-03 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim.
[89719551]
Inspection report failed. Dark line/object appears in the images and the maximum fluoro output exceeds the regulatory limit and the collimation is inadequate and fails for normal mag 1 mag2. On (b)(6): inspection report failed. Dark line/object appears in the images and the maximum fluoro output exceeds the regulatory limit and the collimation is inadequate and fails for normal mag 1 mag2. Then on (b)(6) confirmation of the issue: fse diagnosis & work performed: check system according checklist #(b)(4) found maximum fluoroscopic at 11. 3 r/min, adjusted to 9. 7 for adult and pediatric at 4. 2 and removed a piece of metal between table top and image intensifier witch is blocking the image and check collimator blades all normal. The problem was corrected (as explained above) and that the suspected root cause at this time would be : a miscalibration of the device upon servicing resulting in the maximum output of the system is set to 11. 3 r/min while it should not exceed 10r per minute in fluoro. The setting works when the system is in the automatic mode. This may have resulted in the remote possibility of reaching this maximum output in case a very overweight person had undergone a procedure with this setting. To be noted that the device does not have high level fluoro.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2017-00027 |
| MDR Report Key | 6911112 |
| Date Received | 2017-10-03 |
| Date of Report | 2017-10-03 |
| Date of Event | 2017-08-23 |
| Date Mfgr Received | 2017-10-03 |
| Device Manufacturer Date | 2012-02-29 |
| Date Added to Maude | 2017-10-03 |
| 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-STANDARD |
| Generic Name | HUT EXT DR FINAL ASSY-STANDARD |
| Product Code | IXR |
| Date Received | 2017-10-03 |
| 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 RD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-03 |