MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-23 for LIEBEL-FLARSHEIM HUT IV-HR * manufactured by Liebel-flarsheim.
[152762]
With the pt on the table, under general anesthesia, the cystoscopy table began to move into reverse trendelenberg. No one was touching any of the controls, nor were they able to stop the table when they attempted to do so using the controls. The svc performed found loose hardware in the footswitch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 266551 |
| MDR Report Key | 266551 |
| Date Received | 2000-02-23 |
| Date of Report | 2000-02-22 |
| Date of Event | 2000-02-18 |
| Date Facility Aware | 2000-02-18 |
| Report Date | 2000-02-22 |
| Date Added to Maude | 2000-03-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIEBEL-FLARSHEIM |
| Generic Name | CYSTOSCOPY TABLE |
| Product Code | MMZ |
| Date Received | 2000-02-23 |
| Model Number | HUT IV-HR |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 258045 |
| Manufacturer | LIEBEL-FLARSHEIM |
| Manufacturer Address | 2111 E GALBRAITH RD CINCINNATI OH 45237 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-02-23 |