FDA Adverse Event
Malfunction
Summary report: N
BRILLIANCE 10 AIR
MDR report key: 1881913
·
Received October 6, 2010
Report
- Report Number
- 1525965-2010-00030
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Report Date
- September 8, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K012009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IT IS NOT KNOWN WHETHER A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO ANY DELAY IN DIAGNOSIS, AS THE INVESTIGATION IS ON-GOING. THIS REPORT WILL BE SUBMITTED (B)(4) 2010.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE WILL NOT START ANY EXAMINATION FOR A PT WITH SERIOUS INJURIES ON THE TABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRILLIANCE 10 AIR | JAK | PHILIPS MEDICAL SYSTEMS CLEVELAND), INC. | 728251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |