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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING, INC.; ELECTRODE, PH, STOMACH
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GIVEN IMAGING, INC.; ELECTRODE, PH, STOMACH Back to Search Results
Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2018
Event Type  malfunction  
Event Description
The baby had a ph probe placed at 1500.It comes with a recorder that measures the ph.The mother also records events such as when the baby is eating, sleeping, or when the diaper is changed.At 2115 the mom summoned the rn when she noticed that the recorder had turned off.It was not able to be turned back on.The on-call endo nurse was called but the situation was not resolved.The next morning the company's technical support was called to help retrieve any data that has been saved on the recorder.Despite all efforts they were unable to retrieve any information.The endoscopy unit sent back the defective recorder and they were going to send us a replacement.
 
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Type of Device
ELECTRODE, PH, STOMACH
Manufacturer (Section D)
GIVEN IMAGING, INC.
15 hampshire street
mansfield MA 02048
MDR Report Key7373021
MDR Text Key103585270
Report Number7373021
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 03/14/2018
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 Patient Family Member or Friend
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/14/2018
Event Location Hospital
Date Report to Manufacturer03/14/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/27/2018
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Treatment
NO; NO OTHER THERAPIES
Patient Weight6
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