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

Model Number FGS-0450

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

This report is based on information provided by medtronic investigation personnel.The product sample was not returned to the laboratory, however, a study graph was provided by the customer for analysis.The returned sample did not meet specification as received.The reported condition was confirmed.The investigation found that the reported condition was due to bravo system communication failure.The investigation isolated the failure to the bravo communication failure, but a root cause was not identified.The probable root cause was found to be bravo communication failure.The failure identified on this customer returned sample is a known issue and is addressed in the risk management file.No update to the risk management file is required at this time.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a study that was only one hour.Technical support attempted the customer to upload the study again and they received an effaceee error and technical support told them that it meant there was no data on the recorder.The recorder will be returned for investigation and it worked correctly during the previous procedure.There was no patient and user harm, but a repeat procedure will have to be re-done.

• 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 ; 5920 longbow drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 7610824
• MDR Text Key: 111435275
• Report Number: 9710107-2018-00768
• 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: Other
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• 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
• Date Manufacturer Received: 05/23/2018
• 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: 68 YR
• Patient Weight: 91