Model Number 5392 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/10/2015 |
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.Product event summary: analysis confirmed that the output connector assembly was broken.It was also noted that the main printed circuit board was out of electrical specification.(b)(4).
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Event Description
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It was reported that the atrial and ventricular connectors of the external pulse generator were broken.The epg was returned for repair.There was no patient involvement.
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Manufacturer Narrative
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Further analysis was performed on the main board.Visual inspection revealed no anomalies.Bench analysis found that all tests passed.The error log was reviewed, there were no failures in the log.Conclusion: the main board failure could not be verified.
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Search Alerts/Recalls
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