Catalog Number 99400-000488 |
Device Problems
Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Physio control performed an initial evaluation of the customers device and verified the reported issue.Physio is awaiting repair approval.Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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Event Description
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The customer contacted physio-control to report a non critical issue upon evaluation physio observed a failed energy output test.In this state the device would not be able to deliver appropriate defibrillation therapy if needed.There was no patient use associated with the reported event.
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Event Description
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The customer contacted physio-control to report a non critical issue upon evaluation physio observed a failed energy output test.In this state the device would not be able to deliver appropriate defibrillation therapy if needed.There was no patient use associated with the reported event.
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Manufacturer Narrative
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The customer refused physio-control's recommended repairs and confirmed the device was removed from service.The cause of the reported issue could not be determined.
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Search Alerts/Recalls
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