MAUDE Adverse Event Report: GIVEN IMAGING INC. BRAVO PH MONITORING SYSTEM; CAPSULE

Catalog Number 9FCA

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 04/16/2018

Event Type  malfunction  

Event Description

Bravo capsule was placed in the patient and then the receiver showed "capsule id mismatch." called bravo rep and we were told that nothing could be done at this point to connect the capsule inside the patient and the receiver.

• Brand Name: BRAVO PH MONITORING SYSTEM
• Type of Device: CAPSULE
• Manufacturer (Section D): GIVEN IMAGING INC.
• MDR Report Key: 7464762
• MDR Text Key: 106835848
• Report Number: MW5076794
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9FCA
• Device Lot Number: 38206Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 84