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

Model Number FGS-0634

Device Problem Loss of Data (2903)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Event Description

Patient returned the bravo recorder and reported no issues during the 48 hours of testing.When i tried to upload the data into the software, i got an error message that the recorder was not detected by the software.I called manufacturer, but despite troubleshooting, i was unable to download the data.Manufacturer is replacing the recorder because it's still under warranty and i am sending them this recorder so they can extrapolate the data.I did notify the patient.

• Brand Name: BRAVO CF REFLUX RECORDER
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12134281
• MDR Text Key: 260454853
• Report Number: 12134281
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FGS-0634
• Device Catalogue Number: FGS-0634
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2021
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/08/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA