Model Number FGS-0313 |
Device Problem
Unintended Application Program Shut Down (4032)
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Patient Problem
Sedation (2368)
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Event Date 02/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, they had a short study of 01 hour and 56 minutes.Repeat procedure was performed on a different day.Technical support confirmed with the customer that the issue was the capsule.The recorder worked correctly during the previous procedure.There was no patient and user harm.
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Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, they had a short study of 01 hour and 56 minutes.Repeat procedure was performed on a different day with sedation.Technical support confirmed with the customer that the issue was the capsule.The customer stated that the recorder worked correctly during the previous procedure.There was no patient and user harm.
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Search Alerts/Recalls
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