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

Model Number FGS-0450

Device Problems Loss of Data (2903); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

The accuview graph from the study was returned for evaluation.The total time of the study was 24:54 hours which indicates a performance of a full study and proper function of the bravo ph recorder.There are significant gaps/ignores identified during the study based on discontinuous/interrupted ph values shown in the graph.These gaps occurred mostly during the periods in which the patient was supine.Based on the study analysis review, the most likely reason for gaps in the study was an excessive distance between the recorder and capsule (more than 2 meters away from the capsule) when the patient was supine.The ifu for this device states, the patient must stay within 2 meters (6 feet) of the recorder during the study except, as necessary, for bathing.A review of the device history record was performed and indicates that the product was released meeting finished product specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a short study that showed minimal tracings.The patient did not have any implanted medical devices or high body mass index (bmi).The recorder worked correctly during the previous procedure.There was no harm caused to the patient and a repeat procedure on a different day was performed.

Manufacturer Narrative

Corrected information: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 ; 5920 longbow drive; boulder, CO 80301 ; 7632104064
• MDR Report Key: 7691961
• MDR Text Key: 114559951
• Report Number: 9710107-2018-00834
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• 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
• Patient Age: 62 YR
• Patient Weight: 92