Model Number 2090W |
Device Problem
Programming Issue (3014)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/18/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
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Event Description
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It was reported that the programmer changed over into emergency vvi pacing mode without anyone touching the programmer.It was originally believed to be the analyzer however the analyzer was changed out and the issue persisted.The programmer was returned for service.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: analysis could not confirm the reported event; the programmer passed functional and bench testing.Analysis found the lower case was scratched.
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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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Search Alerts/Recalls
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