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 08/25/2020

Event Type  malfunction  

Event Description

Bravo ph monitoring 96-hour-study was done with patient.Bravo machine was returned by the patient and the data was uploaded.I noticed that the study recorded 67 hours 36 mins only instead of 96-hour.I called technical support and reported the issue, after looking at the study the technician said that the machine was malfunctioned during the study.Report was generated.Assistant manager informed of the incident.The machine was tagged as "out of service/do not use".Device removed from service.Equipment information: bravo ph recorder #3, (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: 10546509
• MDR Text Key: 207335154
• Report Number: 10546509
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2020
• Event Location: Other
• Date Report to Manufacturer: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1