MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0313

Device Problem Unintended Application Program Shut Down (4032)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a study that did not look complete.Technical support was able to log in to the customer's computer, but was not able to complete the file transfer because of the connection.Technical support spoke with the customer and they stated that due to the fact that the duration of the study was only one hour, they will repeat the study.There was no reported patient outcome.

Manufacturer Narrative

Additional information: if information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a study that did not look complete.Technical support was able to logged in to the customer's computer, but was not able to complete the file transfer because of the connection.Technical support spoke with the customer and they stated that due to the fact that the duration of the study was only one hour, a repeat procedure was done.The recorder worked correctly during previous procedure.There was no patient harm.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8305918
• MDR Text Key: 135032547
• Report Number: 9710107-2019-00053
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: 7290101361688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

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: Health Professional
• Device Expiration Date: 08/09/2019
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 41930Q
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2019
• Initial Date FDA Received: 02/05/2019
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 03/26/2019
• Date Device Manufactured: 08/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1