FDA Adverse Event
Malfunction
Summary report: N
BRAVO
MDR report key: 1003427
·
Received February 21, 2008
Report
- Report Number
- 2032545-2008-00825
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Report Date
- January 21, 2008
- Manufacturer
- ARIZONA DEVICE MANUFACTURING
- Product Code
- FFT
- PMA / PMN Number
- K002028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFO IS RECEIVED FROM THE HCP.
Description of Event or Problem · 1
THE HCP REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. NO SERIOUS INJURY TO THE PT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRAVO | FFT | ARIZONA DEVICE MANUFACTURING | 9012B1001 | Q212963 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |