MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-01-17 for BRAVO RFB-0450 manufactured by Given Imaging Ltd., Yoqneam.
[97669893]
Main suspect: was problem with transmit of the capsule. The bravo recorder found serviceable and in compliance to requirements.
Patient Sequence No: 1, Text Type: N, H10
[97669894]
According to the reporter, the bravo recorder was waiting for the capsule after it was calibrated and placed. The led light is red. Technical support had customer turn off the recorder and restart the study and it did not pick up the capsule. Technical support had the customer hold the power button down to reset and it continued to fail. The device is under warranty and will be replaced. The device was returned for investigation. The investigation was done and it was determined that the main suspect was the problem with transmitting of the capsule and the recorder was serviceable and the failure could not be reproduced. There was no patient or user harm due to the alleged device malfunction, but a repeat procedure was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2018-00114 |
| MDR Report Key | 7199167 |
| Report Source | USER FACILITY |
| Date Received | 2018-01-17 |
| Date of Report | 2018-01-17 |
| Date of Event | 2016-07-22 |
| Date Mfgr Received | 2016-07-22 |
| Date Added to Maude | 2018-01-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925297 |
| Manufacturer G1 | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Street | YETSIRA 13 STREET |
| Manufacturer City | YOQNEAM 20692 |
| Manufacturer Postal Code | 20692 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRAVO |
| Generic Name | CAMERA, STILL, SURGICAL |
| Product Code | FTT |
| Date Received | 2018-01-17 |
| Returned To Mfg | 2016-01-03 |
| Model Number | RFB-0450 |
| Catalog Number | RFB-0450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LTD., YOQNEAM |
| Manufacturer Address | YETSIRA 13 STREET YOQNEAM 20692 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-17 |