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

Model Number FGS-0634

Device Problem Data Problem (3196)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2020

Event Type  malfunction  

Event Description

Patient bravo recorder was returned for data to be uploaded in the computer to generate report for ph study.Upon uploading the data, i noticed the time on the bravo recorder was incorrect.It was 6 hours advance.Technical support was called to report the problem.Technician suggest removing the bravo recorder from service and will send a replacement.Ticket# (b)(4) was issued.Bravo machine was tagged "do not use"/ "out of order".Or/endoscopy manager was informed of the incident.Doctor was informed of the incident as well as bio-med.Bravo machine; ref# fgs- 0834; serial# br (b)(4).

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10808627
• MDR Text Key: 215289628
• Report Number: 10808627
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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: 11/02/2020
• Date Report to Manufacturer: 11/09/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1