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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 436010
Device Problem Activation Problem (4042)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2019
Event Type  malfunction  
Event Description
The patient was undergoing placement of a bravo ph probe.When the md removed the introducing catheter, the bravo ph probe had not attached to the patient's esophagus.The pin had deployed, but the probe did not attach as it should.New bravo recalibrated and deployed without incident.Manufacturer given was notified and they will receive faulty equipment back to them for further investigation.
 
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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 Key8581835
MDR Text Key144103240
Report Number8581835
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 Nurse
Type of Report Initial
Report Date 05/03/2019,04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number436010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/03/2019
Event Location Hospital
Date Report to Manufacturer05/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age19345 DA
Patient Weight105
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