FDA Adverse Event
Malfunction
Summary report: N
BRAVO
MDR report key: 1231044
·
Received October 30, 2008
Report
- Report Number
- 2032545-2008-07026
- Event Type
- Malfunction
- Date Received
- October 30, 2008
- Date of Event
- May 13, 2008
- Report Date
- October 8, 2008
- Manufacturer
- ARIZONA DEVICE MANUFACTURING
- Product Code
- FFT
- PMA / PMN Number
- K002028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 CAPSULE WAS RETURNED SEPARATE FROM THE DELIVERY SYSTEM. THE TROCAR NEEDLE WAS ADVANCED WITH NO BLOOD/TISSUE PRESENT. THE PLUNGER WAS FULLY DEPRESSED AND RETRACTED. THE ANALYST FOUND NO VISUAL ANOMALIES OF THE PUSH PIN AND THRUST TIP. THERE WERE BENDS IN THE PUSH/PULL WIRES, DUE TO IT BEING RETURNED BUNCHED UP AND TAPED. THE CAPSULE DID NOT ATTACH.
Description of Event or Problem · 1
THE BRAVO PH MONITOR WAS ORIGINALLY RETURNED FOR AN UNK REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRAVO | FFT | ARIZONA DEVICE MANUFACTURING | 9012B1011 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |