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

Model Number FGS-0450

Device Problems Insufficient Information (3190); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

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 could not transfer the patient data file outside the recorder.The recorder¿s screen would sometimes display error.The recorder was received and technical support tried to download the study, but the recorder displayed eeface error when downloading the data and this denote that the study was corrupted.The customer confirmed that they would perform a repeat procedure.The customer stated that recorder worked correctly during the previous procedure.There was no patient and user harm.

Manufacturer Narrative

Additional information: 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 video files was provided by the customer for analysis.The customer reported they could not transfer the patient data file outside the recorder.The reported condition was confirmed.The investigation found: according to attached file during upload study was showed message "eeface error", this error is displayed only if all data from the recorder was deleted by user.So main suspected mishandling.The investigation identified the cause of the reported event to be data inadvertently deleted (user).For this error exist "bravo ph study was a result of ¿eefface¿ error message.The ¿eefface¿ error pop-up message is a result of trying to download when no data is present in the recorder which occurred due to customers that deleted the study data unintentionally."supporting current bravo ph recorder ¿main screen¿ functions and offering an improved user interface to eliminate the events of ¿eeface¿ error pop-up message display which are the result of an unintentional deletion of study data by the user." 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: 8530206
• MDR Text Key: 142466946
• Report Number: 9710107-2019-00162
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 00290101363064
• UDI-Public: 290101363064
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• 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: 03/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2013
• 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