MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-06 for HYDRA VISION * manufactured by Liebel-flarsheim Company Llc.
[4993724]
It was reported the cysto table malfunctioned, no picture on the monitor screen. The staff member identified a connection loose at the back of the cabinet holding the computer. The staff member reported rad/biomed was called and reconnected this loose connection. Rad/biomed relook at this connection as it was loose again; he came and told me it needed a clamp applied to hold the connections together.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4252773 |
| MDR Report Key | 4252773 |
| Date Received | 2014-11-06 |
| Date of Report | 2014-11-06 |
| Date of Event | 2014-07-28 |
| Report Date | 2014-11-06 |
| Date Reported to FDA | 2014-11-06 |
| Date Reported to Mfgr | 2014-11-15 |
| Date Added to Maude | 2014-11-15 |
| 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 |
| 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 | HYDRA VISION |
| Generic Name | TABLE, CYSTOMETRIC |
| Product Code | KQS |
| Date Received | 2014-11-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIEBEL-FLARSHEIM COMPANY LLC |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US 45237 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-06 |