MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-01 for BRAVO RFB-0450 manufactured by Given Imaging Ltd., Yoqneam.
[137532322]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[137532323]
According to the reporter, the recorder was returned from the patient with a steady red light, but it would not turn on. They attempted to restart the recorder, multiple times, but all attempts failed. Technical support had the customer reset the recorder, but it still failed. The recorder contained the patient data. A repeat procedure will be performed. The customer stated that recorder worked correctly during the previous procedure. There was no patient and user injury.
Patient Sequence No: 1, Text Type: D, B5
[144417012]
Additional information: first name last name, phone#),(e-mail). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[144417013]
.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2019-00075 |
| MDR Report Key | 8381933 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-01 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-03-01 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7632104064 |
| 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 | 2019-03-01 |
| Model Number | RFB-0450 |
| Catalog Number | RFB-0450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-03-01 |