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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM UNKNOWN BRAVO; ELECTRODE, PH, STOMACH
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GIVEN IMAGING LTD., YOQNEAM UNKNOWN BRAVO; ELECTRODE, PH, STOMACH Back to Search Results
Model Number UNKNOWN BRAVO
Device Problem Data Problem (3196)
Patient Problem No Information (3190)
Event Date 11/07/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, they failed to download the study from the recorder.The software had a pop-up message of "there is no data on the recorder or data is corrupted." the recorder worked correctly during the previous procedure.A repeat procedure was necessary scheduled on a different day.There was no reported patient outcome and there was no user harm.
 
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Brand Name
UNKNOWN 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 Key9435216
MDR Text Key170319650
Report Number9710107-2019-00600
Device Sequence Number1
Product Code FFT
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberUNKNOWN BRAVO
Device Catalogue NumberUNKNOWN BRAVO
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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