MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07,08 report with the FDA on 2007-07-13 for HYDRAVISION DR 60 SYSTEM 700539 manufactured by Liebel-flarsheim Co.
[622788]
An operating room nurse reported discovering that a generator on the suspect device was on fire. The suspect device was located in or room at the time of the event. No pt was involved. Machine was operated for less than 30 mins, and smoke came out from the generator. Firstly, main power for the whole system was switch off, and fire extinguisher was used to put off the fire.
Patient Sequence No: 1, Text Type: D, B5
[7814868]
The generator is being returned from the customer facility to manufacturing base. Due to international location, the system will not be back to manufacturing within the required fda time frame of reporting. A follow up supplemental report will be filed once the generator has been returned and evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1518293-2007-00013 |
| MDR Report Key | 880818 |
| Report Source | 04,05,06,07,08 |
| Date Received | 2007-07-13 |
| Date of Report | 2007-06-16 |
| Date of Event | 2007-06-16 |
| Date Mfgr Received | 2007-06-16 |
| Date Added to Maude | 2007-12-04 |
| 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 | 0 |
| Manufacturer Contact | DAVID BENSON |
| Manufacturer Street | 2111 EAST GALBRAITH RD. |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRAVISION DR 60 SYSTEM |
| Generic Name | HYDRAVISION DR UROLOGY SUITE |
| Product Code | MMZ |
| Date Received | 2007-07-13 |
| Model Number | HYDRAVISION DR 60 |
| Catalog Number | 700539 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 921010 |
| Manufacturer | LIEBEL-FLARSHEIM CO |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-13 |