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

Catalog Number FGS0450

Device Problems Loss of Data (2903); Protective Measures Problem (3015)

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

Event Date 07/20/2018

Event Type  malfunction  

Event Description

Concern for device design.Easy for patient to delete/erase information on the device.Patient had bravo ph capsule applied to esophagus.When the receiver box was returned to facility it would not download.Given imaging checked box via remote access and all information had been erased from the box.The patient was an (b)(6) year old and very likely pushed the button to erase the information.Given imaging was unable to retrieve any of the information and the doctor was notified.

• Brand Name: BRAVO PH MONITORING SYSTEM
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7854813
• MDR Text Key: 119501795
• Report Number: 7854813
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FGS0450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2018
• Event Location: Home
• Date Report to Manufacturer: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2920 DA
• Patient Weight: 50