FDA Adverse Event
Malfunction
Summary report: N
BRAVO
MDR report key: 1001692
·
Received February 15, 2008
Report
- Report Number
- 2032545-2008-00743
- Event Type
- Malfunction
- Date Received
- February 15, 2008
- Date of Event
- December 19, 2007
- Report Date
- January 18, 2008
- Manufacturer
- ARIZONA DEVICE MANUFACTURING
- Product Code
- FFT
- PMA / PMN Number
- K002028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS REVEALED NO SIGNIFICANT ANOMALIES. THERE WAS NOT ENOUGH INFO TO DETERMINE THE ROOT CAUSE OF THE FAILURE. THE DEVICE WAS RETURNED WITH THE CAPSULE SEPARATE FROM THE DELIVERY SYSTEM. THE CAPSULE TROCAR NEEDLE FAILED TO ADVANCE. THE PLUNGER HAD BEEN FULLY DEPRESSED AND RETRACTED.
Description of Event or Problem · 1
THE HCP REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD NOT ATTACH TO THE PT'S ESOPHAGUS. THE CAPSULE FELL OFF IN THE PT'S MOUTH. 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 | Q204874 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |