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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BRAVO; ELECTRODE, PH, STOMACH
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COVIDIEN LP BRAVO; ELECTRODE, PH, STOMACH Back to Search Results
Lot Number 508720
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2021
Event Type  No Answer Provided  
Event Description
Bravo reflux recorder unable to sync to bravo probe.Patient underwent egd (esophagogastroduodenoscopy) with bravo ph capsule placement.- rn used a probe requiring calibration with an incorrect recorder box.Prior to patient arrival - rn spoke with associate tech user support analysis with medtronic.The tech reviewed each step with rn and confirmed the recorder was ready for use.The monitor displayed start study and the tech support stated it meant it was ready for use with the patient's capsule.The menus for patient to select from were not present and that the recorder did not work with the patient probe placed in patient.Rn contacted medtronic and was told the probe used needed calibrating.How could this happen? medtronic tech support stated "perhaps the person i spoke with was not a proper tech." no patient harm.This was user error, staff and tech support.
 
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Brand Name
BRAVO
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key11284972
MDR Text Key230465280
Report Number11284972
Device Sequence Number1
Product Code FFT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Lot Number508720
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2021
Event Location Hospital
Date Report to Manufacturer02/05/2021
Type of Device Usage Unknown
Patient Sequence Number1
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