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

Lot Number LOT#40532Q

Device Problems Calibration Problem (2890); Output Problem (3005)

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

Event Date 05/13/2019

Event Type  malfunction  

Event Description

Bravo ph probe equipment failure unable calibrate capsule error message.This is a disposable one time use item that would not work and we did not have another of these capsules in stock.The case had to be cancelled and rescheduled.The leader in this department called the manufacturer to let them know that we had a problem with their product.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC/COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8878849
• MDR Text Key: 153831818
• Report Number: 8878849
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: LOT#40532Q
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 103