Model Number 5392 |
Device Problems
Degraded (1153); Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Product event summary: manufacturer's analysis confirmed the customer comment that the device had an error that would not clear.It was also noted that both wires on the liquid crystal display (lcd) were pinched without compromise, however the red wire was exposed.The wires were also routed incorrectly over the battery compartment.All found defective parts were replaced and all other identified issues were resolved.A good faith effort will be made to obtain the applicable information relevant to the report.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 the external pulse generator (epg) presented with an error that would not clear.The epg has been returned for repair.There was no patient involvement.It was further reported that the returned epg subsequently tested out of specification during manufacturer¿s analysis.
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Manufacturer Narrative
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Failure analysis was performed on the main board.Visual inspection revealed no anomalies.The main board was then assembled into a golden unit.The device powered on to an error.The eeprom (electrically erasable programmable read-only memory) was then replaced.The device was run on the automated test console and all tests passed.The logs were reviewed.Three different errors were displayed in the logs.Conclusion: the customer complaint of an error on power-up was confirmed.The failure was caused by a corrupt eeprom.One error was confirmed in the log, but could not be reproduced on the bench.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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