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

Model Number FGS-0313

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/17/2019

Event Type  malfunction  

Event Description

The bravo capsule was initially calibrated and paired with the external receiver.The physician placed the bravo reflux capsule into the patient's esophagus.Start study was then pressed on the receiver.The receiver kept giving a message to calibrate the bravo capsule.Several attempts were made to bypass the calibrate capsule message.An attempt was made to pair with a different receiver.But, this did not work either.Bravo tech support was contacted.After trouble shooting the receiver with bravo, bravo determined that the only option was to remove the capsule and start over with another capsule.The capsule was removed.The patient declined to have another bravo capsule placed.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9590813
• MDR Text Key: 175065942
• Report Number: 9590813
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 47325Q
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10950 DA