FDA Adverse Event
Malfunction
Summary report: N
BRAVO
MDR report key: 1030947
·
Received April 17, 2008
Report
- Report Number
- 2032545-2008-02026
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- February 21, 2008
- Report Date
- March 17, 2008
- Manufacturer
- ARIZONA DEVICE MANUFACTURING
- Product Code
- FFT
- PMA / PMN Number
- K002028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- 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 FULLY ADVANCED WITH SOME BLOOD/TISSUE PRESENT. THE PLUNGER WAS FULLY DEPRESSED AND RETRACTED. THE ANALYST DID A VISUAL INSPECTION OF THE PUSH/PULL WIRES AND FOUND NO ABNORMALITIES.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE PLACING THE BRAVO PH MONITOR, THE CAPSULE DID NOT ATTACH TO THE PATIENT'S ESOPHAGUS. THE CAPSULE FELL OFF INTO THE PATIENT'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 | Q210552 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |