MAUDE Adverse Event Report: GIVEN IMAGING LOS ANGELES BRAVO; ELECTRODE, PH, STOMACH

Device Problems Break (1069); No Display/Image (1183); Failure to Power Up (1476)

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

Event Date 02/04/2019

Event Type  malfunction  

Event Description

When the bravo was verified for connection to bravo capsule and box battery fully charged.After placement in the esophagus the box was working, blue light on and screen with the images.Patient in recovery room and ready for discharge.Went to go over the box with the patient and the screen was black and would not turn back on.Medtronic technical support unable to restart and case needed to be rescheduled with a new box in the future.The broken bravo removed from service and awaiting replacement to return the non-working one.The patient has to return to have the bravo re-placed.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LOS ANGELES; 5860 uplander way; culver city CA 90230
• MDR Report Key: 8394023
• MDR Text Key: 137939946
• Report Number: 8394023
• Device Sequence Number: 0
• Product Code: FFT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA