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

Model Number FGS-0450

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2020

Event Type  malfunction  

Event Description

Bravo machine used for ph monitoring was returned by the patient.The data was uploaded from the machine three days later.Report was generated and i noticed that the saved study was only 63:42 hours instead of the set study duration of 96 hours.Technical support was contacted to report the incident.Based on the technician evaluation, the machine malfunctioned, and the study was not completed.Manager was informed of the incident.Bravo machine #1 was removed from service, was tagged "out of service/ do not use".Bravo machine information.Bravo ph recorder #1.Ref # fgs-0450.Serial: (b)(4).Bravo capsule - lot# 48063q ; id# (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: 10559698
• MDR Text Key: 207728173
• Report Number: 10559698
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FGS-0450
• Device Catalogue Number: FGS-0450
• Device Lot Number: 48063Q
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2020
• Date Report to Manufacturer: 09/21/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1