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

Device Problem Communication or Transmission Problem (2896)

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

Event Date 07/24/2019

Event Type  malfunction  

Event Description

Bravo capsule was calibrated.Capsule deployed.Failed to transmit to receiver.

Event Description

Bravo capsule was calibrated.Capsule deployed.Failed to transmit to receiver.Manufacturer response for bravo capsule, bravo (per site reporter).

• Brand Name: BRAVO CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LOS ANGELES; 5860 uplander way; culver city CA 90230
• MDR Report Key: 9165789
• MDR Text Key: 161550668
• Report Number: 9165789
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

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: Health Professional
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/15/2019
• Patient Sequence Number: 1
• Patient Age: 18250 DA