MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-03 for HUT EXT DR FINAL ASSY-STANDARD 404008 manufactured by Liebel-flarsheim.
[123511809]
Initial complaint received on (b)(6) 2018. Reporter notified guerbet regarding an incident as described as monitor 1 no sync and no lights on viewmant hand control. Report receiver spoke with the biomed, who stated that this is an older 2004 hut dr with an lf 04 or lf 05 video distribution box. The video distribution box is only getting about 3v dc and so is not operating. Report receiver instructed reporter to find the 7. 5v dc video distribution power supply on the right side of the table. Reporter found it and determined it to be faulty. He wants to do the repair by himself and does not want an fse to come to the site. This event occurred during a procedure, this procedure was not completed, and was rescheduled. There was no reported injuries ot patient or staff. The procedure in this case was rescheduled, and as such, having to repeat a procedure where a patient needs to go under general anesthesia, potential re-exposure to x-ray, and the lack of maintenance information since it will be done locally, this case is considered for mdr reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2018-00036 |
| MDR Report Key | 7931992 |
| Date Received | 2018-10-03 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2004-05-31 |
| Date Added to Maude | 2018-10-03 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | 2018-10-03 |
| 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 ROAD CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-03 |