FDA Adverse Event
Other
Summary report: N
BRILLIANCE BR 40
MDR report key: 1583378
·
Received January 21, 2010
Report
- Report Number
- 1525965-2010-00001
- Event Type
- Other
- Date Received
- January 21, 2010
- Date of Event
- December 23, 2009
- Report Date
- December 23, 2009
- Manufacturer
- PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
- Product Code
- JAK
- PMA / PMN Number
- K033326
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER OF THE INJECTOR IS MALLINCKRODT WHO IS NOW OWNED BY COVIDIEN. (B)(4).
Description of Event or Problem · 1
PHILIPS HEALTHCARE RECEIVED A CUSTOMER COMPLAINT WHICH STATED "AN AIR BUBBLE HAD BEEN INJECTED INTO A PATIENT." UPON FURTHER INVESTIGATION INTO THIS ISSUE, THE HOSPITAL HAS DETERMINED THAT THE INCIDENT WAS NOT "EQUIPMENT RELATED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRILLIANCE BR 40 | BR 40 JAK | JAK | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. | 728235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |