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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/04/2018

Event Type  malfunction  

Event Description

During the gastroscopies, four patients returned with inconclusive ph test results.Manufacturer response for bravo ph monitoring system, (brand not provided) (per site reporter).The representative provided replacement capsules.

• Brand Name: BRAVO PH MONITORING SYSTEM
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, LTD.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8288294
• MDR Text Key: 134494992
• Report Number: 8288294
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/11/2019

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2019
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1