FDA Adverse Event
Malfunction
Summary report: N
S5/S5I SERIES INTRAVASCULAR IMAGING SYSTEM
MDR report key: 2852169
·
Received November 12, 2012
Report
- Report Number
- 2939520-2012-00068
- Event Type
- Malfunction
- Date Received
- November 12, 2012
- Date of Event
- October 15, 2012
- Report Date
- October 15, 2012
- Manufacturer
- VOLCANO CORPORATION
- Product Code
- IYO
- PMA / PMN Number
- K111706
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INTERNAL REFERENCE: (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR¿S INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE MFR FIELD SERVICE ENGINEER REPORTED THAT THE CUSTOMER TRIED TO TURN ON THE IMAGING SYSTEM AND OBSERVED THAT THE POWER BUTTON WAS FLASHING. A SMOKY SMELL APPEARED TO BE COMING FROM THE INSIDE OF THE IMAGING SYSTEM. IT WAS FURTHER REPORTED THAT THERE WAS NO ON-ONGOING PROCEDURE AND NO PT PRESENT AT THE TIME WHEN THE INCIDENT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S5/S5I SERIES INTRAVASCULAR IMAGING SYSTEM | SYSTEM, IMAGING, PULSED ECHO, ULTRASOUND | IYO | VOLCANO CORPORATION | 8073000015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |