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 04/24/2015 |
Event Type
malfunction
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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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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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Manufacturer Narrative
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Product event summary: analysis was not able to confirm the customer comment that the programmer went into emergency vvi pacing mode without the programmer being touched, it did not enter into emergency vvi unless the button was pressed.Analysis did find that the system fan was noisy and that the electrocardiogram connector on the link electronic module (lem) board was loose.Both the fan and the lem board were replaced and the board was calibrated as well.
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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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