Model Number 5392 |
Device Problems
Connection Problem (2900); Material Integrity Problem (2978)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/13/2019 |
Event Type
malfunction
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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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It was reported that both the atrial and ventricular inputs of the external pulse generator (epg) were broken, and would not hold leads.The epg has been returned for repair.There was no patient involvement.
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Manufacturer Narrative
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Failure analysis was performed on the main board.Visual inspection: no anomalies.Benchtop analysis: assembled into a golden unit.Ran on automated test console.Passed atrial pulse noise test, 68.47mv.Measured atrial pulse noise is within the requirements of the atrial pulse noise test (0-100 mv).Logs analyzed, no anomalies.Conclusion: no defect found.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: manufacturer¿s analysis confirmed the customer comment that both connectors of the external pulse generator (epg) were broken.It was also found that the hanger was broken, the main printed circuit board (pcb) was out-of-specification in an electrical manner, and one case screw was contaminated.All found defective parts were replaced and all other identified issues were resolved.The device passed all final functional tests.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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