FDA Adverse Event
Malfunction
Summary report: N
S5 IMAGING SYSTEM
MDR report key: 1197623
·
Received October 13, 2008
Report
- Report Number
- 2939520-2008-00023
- Event Type
- Malfunction
- Date Received
- October 13, 2008
- Date of Event
- September 16, 2008
- Report Date
- October 14, 2008
- Manufacturer
- VOLCANO CORP
- Product Code
- IYO
- PMA / PMN Number
- K061215
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE SYSTEM AND MATERIALS HAVE BEEN DESIGNED AND TESTED TO IEC 60601-1 TO ENSURE THAT THE POSSIBILITY OF A FIRE OCCURRING IS VERY REMOTE. ALTHOUGH, THERE WAS NO INJURY THAT OCCURRED DUE TO THIS MALFUNCTION, THERE IS THE POSSIBILITY THAT IF IT WERE TO RECUR, A NEGATIVE IMPACT TO OTHER EQUIPMENT AND/OR MATERIALS IN THE ROOM (I.E. COMPRESSED GAS TANKS, FLAMMABLE MATERIALS, ECT.) COULD RESULT IN HARM TO THE PT/USER. THIS REPORT IS BEING SENT AS A NOTIFICATION.
Description of Event or Problem · 1
SMOKE CAME OUT OF THE BACK OF THE SYSTEM WHEN IT WAS TURNED ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S5 IMAGING SYSTEM | IVUS IMAGING SYSTEM | IYO | VOLCANO CORP | 804200001-R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |