FDA Adverse Event
Other
Summary report: N
*
MDR report key: 974257
·
Received May 21, 2007
Report
- Report Number
- 9613347-2007-00013
- Event Type
- Other
- Date Received
- May 21, 2007
- Manufacturer
- STORZ MEDICAL AG
- Product Code
- NCV
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
PREVIOUS TO AND DURING THIS PROCEDURE, THE OPERATORS OF THE UNIT NOTICED IT MADE LOUD NOISES AND EMITTED NOXIOUS FUMES, BUT THE DID NOT CALL FOR SVC. AFTER IT FAILED, SYS WAS SERVICED ON 3/22/07 FOR A BAD HIGH VOLTAGE GENERATOR (LTG). ALSO REPLACED HV PLUG ON PSC AND BLOW FLANGE. WHAT THE HOSP WAS REPORTING, WAS THE INTERRUPTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | NCV | STORZ MEDICAL AG | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |