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

Model Number FGS-0634

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the recorder would not power on and there was no led display.Technical support had the customer press and hold the power button for seven seconds and then pressed the button again, but the recorder did not power on.Technical support had the customer press the power button again for 10 seconds and then pushed the power button again, but there was still no power or led display on the recorder.Technical support advised the customer to place the recorder on wall charger overnight.Technical support called the customer to confirm if the recorder powered on after charging overnight, but the customer stated that the recorder was still not powering on even after attempting a hard reset.The data upload failed with error and 48.5 hours of unusable data was detected at the end of the study which was already removed.The recorder worked correctly during the previous procedure.There was no patient and user harm and a repeat procedure was necessary.

Manufacturer Narrative

Evaluation summary: this report is based on information provided by medtronic investigation personnel.The bravo was received for evaluation.The returned sample did not meet specification as received by medtronic.The visual inspection found no notable conditions.The customer reported the data upload failed with error and 48.5 hours of unusable data was detected at the end of the study which was already removed.The reported condition was confirmed.The investigation found that data on the recorder is corrupted, this was led to the reported problem.The investigation found the most probable cause to be the data failure.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the recorder would not power on and there was no led display.Technical support had the customer press and hold the power button for seven seconds and then pressed the button again, but the recorder did not power on.Technical support had the customer press the power button again for 10 seconds and then pushed the power button again, but there was still no power or led display on the recorder.Technical support advised the customer to place the recorder on wall charger overnight.Technical support called the customer to confirm if the recorder powered on after charging overnight, but the customer stated that the recorder was still not powering on even after attempting a hard reset.The data upload failed with error and 48.5 hours of unusable data was detected at the end of the study which was already removed.The recorder worked correctly during the previous procedure.The recorder has been returned for investigation, disassembled, and tested and it revealed that no useful information could be downloaded from the recorder.There was no patient and user harm and a repeat procedure was necessary.

Manufacturer Narrative

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

• 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: 9220429
• MDR Text Key: 163213349
• Report Number: 9710107-2019-00502
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369691
• UDI-Public: 07290101369691
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0634
• Device Catalogue Number: FGS-0634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• 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
• Patient Age: 36 YR
• Patient Weight: 74