FDA Adverse Event
Malfunction
Summary report: N
INTEGRIS CV
MDR report key: 2021412
·
Received February 8, 2011
Report
- Report Number
- 3003768277-2011-00152
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Report Date
- January 18, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZI
- PMA / PMN Number
- K984545
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS EVENT IS STILL UNDER INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT BY 04/16/2011.
Description of Event or Problem · 1
THERE IS NO EXPOSURE DURING PROCEDURE. CUSTOMER HAD REBOOTED VIEWING SUBSYSTEM. WHEN THE SYSTEM WAS FIRST BOOT UP, THE VIEWING SUBSYSTEM DID NOT COMMUNICATE WITH SYSTEM CONTROLLER. THE OPERATION WAS CHECKED. NO OTHER PROBLEMS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRIS CV | IZI | PHILIPS HEALTHCARE | 722030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |