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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BRAVO PH BOX TRANSMITTER; ELECTRODE, PH, STOMACH
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COVIDIEN LP BRAVO PH BOX TRANSMITTER; ELECTRODE, PH, STOMACH Back to Search Results
Device Problems Break (1069); Crack (1135)
Patient Problem Insufficient Information (4580)
Event Date 09/21/2020
Event Type  malfunction  
Event Description
Patient had egd (esophagogastroduodenoscopy) and ph bravo placed.Bravo box was new and had never been used on a patient.Box and case were returned cracked and damaged.Biomed was called and was able to put box together, so study could be uploaded.Spoke with mom to ask if they could remember damaging the equipment.Mom denied any problems.Family returned the equipment broken and when mom was asked what happened, she informed the team member that it wasn't her or her son's fault, it was probably someone from the hospital who picked it up and dropped it on the way to the unit.Bravo box was under warranty, replacement was sent, and clinical engineer tech sent broken box back to the manufacturer.
 
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Brand Name
BRAVO PH BOX TRANSMITTER
Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
COVIDIEN LP
15 hampshire street
mansfield MA 02048
MDR Report Key12106654
MDR Text Key259636405
Report Number12106654
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 Other Health Care Professional
Type of Report Initial
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/22/2021
Event Location Hospital
Date Report to Manufacturer07/02/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/02/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age4745 DA
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