MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-13 for HUT EXT DR FINAL ASSY-REVERSE 404007 manufactured by Liebel-flarsheim.
[114543772]
Customer reports that device is in error stating monitor collision with table, tilts 20 degrees, and the table thinks the tube head is hitting the monitors but it is not. Table is tilted with feet in the air about 20 degrees. Upon follow-up call, customer stated that he was able to get the table down and tilted the head back up to level by using the collision override button. When this incident originally occured, the patient had to be taken off the table with the table tilted head down and higher than they wanted it. He did not have knowledge, however, if the case was completed. Upon follow-up call on (b)(6) 2018, customer stated that the table is tilted head down, 20 degrees, which is the max head down. When they try and tilt the head end back up, they get the message, monitor collision. Additionally, the table will down move down elevation; only up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2018-00022 |
| MDR Report Key | 7685203 |
| Date Received | 2018-07-13 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-06-14 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2008-08-31 |
| Date Added to Maude | 2018-07-13 |
| 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 |
| 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-REVERSE |
| Generic Name | HUT EXT DR FINAL ASSY-REVERSE |
| Product Code | IXR |
| Date Received | 2018-07-13 |
| 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 ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-13 |