MAUDE Adverse Event Report: COVIDIEN LP BRAVO CF REFLUX RECORDER; ELECTRODE, PH, STOMACH

Model Number FGS-0634

Device Problems Display or Visual Feedback Problem (1184); Use of Device Problem (1670); Complete Loss of Power (4015)

Patient Problem Insufficient Information (4580)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

Patient had a bravo capsule placed during an egd.The recorder was fully charged and functioning when the patient left.Her father called at 11am (they live 1.5 hours away) and told me the recorder had no power.When they returned, the recorder was blank.I plugged it into the charger and it had defaulted to factory settings.I was able to connect another recorder so the patient could still have the testing done.

• Brand Name: BRAVO CF REFLUX RECORDER
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12576426
• MDR Text Key: 274738759
• Report Number: 12576426
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13140 DA