FDA Adverse Event
Other
Summary report: N
BRILLIANCE 64
MDR report key: 2992704
·
Received March 1, 2013
Report
- Report Number
- 1525965-2013-00035
- Event Type
- Other
- Date Received
- March 1, 2013
- Date of Event
- May 18, 2011
- Report Date
- May 19, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K033326
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO JANUARY OF 2007. THE SYSTEM WAS TAKEN OUT OF SERVICE UNTIL THE FIELD SAFETY ENGINEER (FSE) ARRIVED. A REPLACEMENT PART (CT BOX) WAS ORDERED AND INSTALLED. THE FAILED UNIT WAS RETURNED THROUGH NORMAL SERVICE CHANNELS. NO ROOT CAUSE WAS DETERMINED. (B)(4).
Description of Event or Problem · 1
PHILIPS RECEIVED A REPORT THAT WHEN TURNING THE CT BOX KEY TO START THE SYSTEM THE MEDICAL ASSISTANT RECEIVED A SHOCK. NO ADDITIONAL INFORMATION WAS RECEIVED IN REGARDS TO THE OPERATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89853 | BRILLIANCE 64 | JAK | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 728231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |