MAUDE Adverse Event Report: GIVEN IMAGING BRAVO CAPSULE

Model Number ID#C37E

Device Problem No Display/Image (1183)

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

Event Date 06/06/2016

Event Type  malfunction  

Event Description

Scheduled egd with bravo capsule placement to measure ph for 48 hours.Recorder did not show on the screen.Imaging representative called tech support.May need to repeat egd.

• Brand Name: BRAVO CAPSULE
• Type of Device: BRAVO CAPSULE
• Manufacturer (Section D): GIVEN IMAGING; yogneam IL 20692
• MDR Report Key: 5722830
• MDR Text Key: 47408648
• Report Number: MW5062787
• Device Sequence Number: 1
• Product Code: FFT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ID#C37E
• Device Lot Number: 29780Q
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR