BRAVO Adverse Event — Malfunction (MDR 2032545-2008-00704)
BRAVO Adverse Event — Malfunction (MDR 2032545-2008-00704) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BRAVO; Manufacturer: ARIZONA DEVICE MANUFACTURING; Report number: 2032545-2008-00704.
| Device | BRAVO |
|---|---|
| Manufacturer | ARIZONA DEVICE MANUFACTURING |
| Report number | 2032545-2008-00704 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | User facility |
| Narrative | THE HCP REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD NOT ATTACH TO THE PT'S ESOPHAGUS. THE CLINICIAN FELT THAT THE CAPSULE TROCAR DID NOT COMPLETELY ADVANCE. THE CAPSULE FELL OFF THE DELIVERY SYS UPON REMOVAL FROM THE PT. NO SERIOUS INJURY TO THE PT WAS REPORTED. |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →