MAUDE Adverse Event Report: GIVEN IMAGING INC. BRAVO; ELECTRODE, PH, STOMACH

Lot Number 38687Q

Device Problems Calibration Problem (2890); Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2018

Event Type  malfunction  

Event Description

The bravo device and recorder calibrated.It was noted that the calibration took longer than normal but was successful.The bravo device was deployed by md without incident.When bravo recorder was turned on it was unable to connect with the bravo device.Talked to given/medtronic's technical support and they were unable to help the bravo device and recorder connect.Manufacturer response for bravo recorder, bravo (per site reporter).A help line was contacted to assist with connection.The medtronic help line was unable to successfully connect the device.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7493881
• MDR Text Key: 107587588
• Report Number: 7493881
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/08/2019
• Device Lot Number: 38687Q
• Other Device ID Number: BE8B
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2018
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20 YR