MAUDE Adverse Event Report: MEDTRONIC INC/GIVEN IMAGING INC. BRAVO PH RECORDER; ELECTRODE, PH, STOMACH

Model Number FGS-0450

Device Problem Unexpected Shutdown (4019)

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

Event Date 07/07/2020

Event Type  malfunction  

Event Description

Given imaging bravo ph recorder would turn off following the start of the study.Several attempts were made, and technical support was contacted with the same result.Study unable to be completed at this time.Fda safety report id # (b)(4).

• Brand Name: BRAVO PH RECORDER
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC INC/GIVEN IMAGING INC.; minneapolis MN 55432
• MDR Report Key: 10257295
• MDR Text Key: 198497123
• Report Number: MW5095459
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0450
• Device Catalogue Number: FGS-0450
• Was Device Available for Evaluation?: Yes
• 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: 69 YR