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

Model Number FGS-0450

Device Problem Loss of Data (2903)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the bravo recorder was received with the study¿s data.Upload data by accuview ph-z 5.2 was failed, error message appeared-¿cannot upload data¿.Connected the recorder to sw "bravo utility" and 227 files were found, that corresponds to 48 hours of recording time.However, the files were checked in the r<(>&<)>d and it was found that this files are empty (missing data).Therefore customer could not save the study (corrupted files).Note that complainant said that study is 18 hours however according to files it is clear that it was 48 hours.Not clear what the complainant saw after 18 hours.Main suspicion unknown bug of the software.

Event Description

According to the reporter, the customer called to report a bravo study that ended after 18 hours.The customer reported they were unable to save the study and then it was deleted from the recorder when attempting to upload the study.A repeat procedure was necessary.

• 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: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925297
• MDR Report Key: 7160049
• MDR Text Key: 96370423
• Report Number: 9710107-2018-00023
• Device Sequence Number: 1
• Product Code: FFT
• 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
• Report Date: 01/03/2018

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: Health Professional
• Device Model Number: FGS-0450
• Device Catalogue Number: FGS-0450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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