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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LOS ANGELES BRAVO; ELECTRODE, PH, STOMACH
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GIVEN IMAGING LOS ANGELES BRAVO; ELECTRODE, PH, STOMACH Back to Search Results
Device Problems Calibration Problem (2890); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2017
Event Type  malfunction  
Event Description
When calibrating bravo capsule prior to a procedure, the calibration failed on buffer solution ph 1.07.The case was delayed while a second capsule was prepared.A second capsule failed with calibration of ph 1.07.A third capsule was prepared using a different lot number, new bottle of buffer solution and a different receiver.The calibration failed again.The given representative was notified and came to endoscopy.A fourth capsule from a different lot number, new buffer solution and a different receiver was set up with the rep present.The procedure then was performed without any difficulties.No bravo capsule identifying information was documented in the event report.Event reporter has been contacted for additional information.Manufacturer response for reflux capsule, bravo reflux capsule (per site reporter): no response to date.
 
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Brand Name
BRAVO
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING LOS ANGELES
5860 uplander way
culver city CA 90230
MDR Report Key6313771
MDR Text Key66876598
Report Number6313771
Device Sequence Number1
Product Code FFT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2017
Is this a Product Problem Report? Yes
Device Operator Nurse
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/25/2017
Event Location Hospital
Date Report to Manufacturer01/25/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age60 YR
Patient Weight84
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