MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for BRAVO RFB-0450 manufactured by Given Imaging Ltd., Yoqneam.
[134447706]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[134447707]
According to the reporter, ten and a half hours after capsule placement, the recorder displayed error code? 386err_j2c024/driver? And it turned off. The customer press and hold power button for 30 seconds, but there was no response. The customer then pressed circle, triangle, square and circle buttons, but there was no change in error state. A repeat procedure will be performed. The customer noted that the recorder worked correctly during previous procedure. There was no patient injury. The device will be returned for data extraction.
Patient Sequence No: 1, Text Type: D, B5
[138888715]
Additional information: evaluation summary: this report is based on information provided by medtronic investigation personnel. The bravo recorder was received for evaluation. The returned sample met specification as received by medtronic. The visual inspection found no issues. The customer reported that ten and half hours after capsule placement, the recorder displayed error code? 386err_j2c024/driver?. The reported condition was not confirmed. The investigation found the device to function normally and within specifications. The investigation could not determine a cause or a probable root cause for the customer's report based on the information provided. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[138888716]
According to the reporter, ten and half hours after capsule placement, the recorder displayed error code? 386err_j2c024/driver? And it turned off. The customer press and hold power button for 30 seconds, but there was no response. The customer then pressed circle, triangle, square and circle buttons, but there was no change in error state. A repeat procedure will be performed. The customer noted that the recorder worked correctly during previous procedure. There was no patient harm. The device will be returned for data extraction. Technical support received, disassembled and tested the recorder broke down when they were attempting to extract information. After many attempts data was downloaded via software version 6.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710107-2019-00040 |
| MDR Report Key | 8283911 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-03-06 |
| Date of Event | 2018-12-26 |
| Date Mfgr Received | 2019-02-10 |
| Date Added to Maude | 2019-01-28 |
| 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 | 2019-01-28 |
| Returned To Mfg | 2019-01-16 |
| Model Number | RFB-0450 |
| Catalog Number | RFB-0450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-01-28 |