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

Model Number FGS-0634

Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019); Key or Button Unresponsive/not Working (4063)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

Patient had bravo capsule placed and discharged home with bravo recorder.Patient then noticed recorder "shut off" and unable to restart recorder by pressing any button to wake it up.Called on call nurse who tried to troubleshoot, unable to restart recorder.Nurse called md who advised patient to return recorder in am.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11594743
• MDR Text Key: 243131808
• Report Number: 11594743
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA