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

Model Number FGS-0636

Device Problems Mechanical Problem (1384); Blocked Connection (2888)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2020

Event Type  malfunction  

Event Description

Bravo calibration free capsule deployed by md and each time capsule failed to attach to the esophagus.Manufacturer response for electrode, ph, stomach, bravo (per site reporter): hospital notified manufacturer representative.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12158270
• MDR Text Key: 261314206
• Report Number: 12158270
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 50607F ID BC6EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 41