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

Model Number FGS-0450

Device Problems Signal Artifact/Noise (1036); Unintended Application Program Shut Down (4032)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel.The product sample was not returned to the medtronic laboratory; however, a study graph was provided by the customer for analysis.The returned sample did not meet specification as received by medtronic.The customer reported bravo short study.The reported condition was confirmed.The investigation isolated the failure to the bravo communication system, but a cause was not identified.No trend has been identified.A review of the device history records indicated that this serial number was released meeting all specifications as manufactured.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a short study.A copy of the study was provided for review.Technical support confirmed that there was a big area of missing tracings.The patient did not gotten too far away from the device and the patient stated that it was flashing red in the first part of study and never shut off.The patient was able to press on the screen, but when they uploaded the report it was incomplete.The patient did not have any implants.The recorder worked correctly during the previous procedure.There was no patient and user harm.A repeat procedure was necessary scheduled on a different day.

• 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: 8326501
• MDR Text Key: 135879400
• Report Number: 9710107-2019-00059
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101363064
• UDI-Public: 07290101363064
• 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
• Report Date: 02/11/2019

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 Model Number: FGS-0450
• Device Catalogue Number: FGS-0450
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22 YR