FDA Adverse Event
Malfunction
Summary report: N
OMNIPULSE-MAX
MDR report key: 1250063
·
Received December 4, 2008
Report
- Report Number
- 1419951-2008-00009
- Event Type
- Malfunction
- Date Received
- December 4, 2008
- Date of Event
- October 3, 2008
- Report Date
- December 4, 2008
- Manufacturer
- TRIMEDYNE, INC.
- Product Code
- GEX
- PMA / PMN Number
- K041660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON 10/09/2008, CUSTOMER CANCELED SERVICE ON THIS LASER. NO FURTHER EVALUATION WAS PERFORMED.
Description of Event or Problem · 1
IN 2008, IT WAS REPORTED THAT THE SYSTEM EXHIBITED "LOW ENERGY OUTPUT". DURING A SUBSEQUENT EVALUATION PERFORMED AT ABOUT 7 DAYS LATER, IT WAS FOUND THAT THE "BLAST SHIELD HOLDER AND BLAST SHIELD CAP WERE PARTIALLY MELTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIPULSE-MAX | HO:YAG LASER SYSTEM | GEX | TRIMEDYNE, INC. | 1210-VHP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |