FDA Adverse Event
Malfunction
Summary report: N
ALLURA XPER FD20
MDR report key: 1912488
·
Received November 22, 2010
Report
- Report Number
- 3003768277-2010-00327
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Date of Event
- October 28, 2010
- Report Date
- October 28, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZI
- PMA / PMN Number
- K031333
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(CONCLUSIONS) - THE ROOT CAUSE WAS FOUND TO BE THE RESULT OF THE TABLE SIDE OPERATING MODULE (TSO) CABLE BEING PULLED OUT. THE HOSPITAL'S ENGINEER CORRECTED THIS FAULT. THERE HAVE BEEN NO PREVIOUS REPORTED PROBLEMS ON THE STOP BUTTON. THERE IS NO NEEDED MANDATORY FIELD ACTION. (B)(4).
Description of Event or Problem · 1
THIS X-RAY SYSTEM'S EMERGENCY STOP BUTTON WOULD NOT ACTIVATE. THE PT WAS ON THE TABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLURA XPER FD20 | IZI (SYSTEM, X-RAY ANGIOGRAPHIC) | IZI | PHILIPS MEDICAL SYSTEMS | 722006 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |