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

Model Number FGS-0634

Device Problem High pH (2426)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

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 study had multiple exclusions due to high ph.A repeat procedure was necessary.The recorder and work station software worked correctly during the previous procedure.There was no patient and user harm.

Manufacturer Narrative

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

Event Description

According to the reporter, the study had multiple exclusions due to high ph.A repeat procedure was performed on a different day.The recorder and work station software worked correctly during the previous procedure.There was no patient and user harm.

• Brand Name: BRAVO PH MONITORING SYSTEM AND ACCESSORIES
• 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: 8586534
• MDR Text Key: 144277326
• Report Number: 9710107-2019-00205
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369691
• UDI-Public: 07290101369691
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2019
• Date Device Manufactured: 08/31/2018
• 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
• Patient Age: 59 YR
• Patient Weight: 117