FDA Adverse Event
Malfunction
Summary report: N
QUANTA SYSTEM S.P.A.
MDR report key: 3232314
·
Received December 21, 2012
Report
- Report Number
- 3004378299-2012-00004
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- May 14, 2012
- Report Date
- December 18, 2012
- Manufacturer
- QUANTA SYSTEM, S.P.A.
- Product Code
- GEX
- PMA / PMN Number
- K100558
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- EMERGENCY MEDICAL TECHNICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LASER SYSTEM HAD PROBLEM AT CABLE OF DIODE POWER-SUPPLY, THIS CONDITION CREATED OVERHEATING AND THEN POWERDROP. WE ARE UNAWARE ABOUT DELAY ON TREATMENT OR PATIENT INJURY.
Description of Event or Problem · 1
THE LASER SYSTEM HAD OVERHEATING AND THEN POWERDROP. WE ARE UNAWARE ABOUT DELAY ON TREATMENT OR PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUANTA SYSTEM S.P.A. | SURGICAL LASER | GEX | QUANTA SYSTEM, S.P.A. | QUANTA 1470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |