Model Number 5392 |
Device Problems
Operating System Becomes Nonfunctional (2996); Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/30/2018 |
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 the external pulse generator (epg) was freezing up.The status of the epg is unknown.There was no patient involvement.
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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 further reported that the epg has been returned for repair.
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Manufacturer Narrative
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Product event summary: manufacturer¿s analysis confirmed the customer comment that the external pulse generator (epg) would freeze when turned on; the main printed circuit board (pcb) tested out-of-specification in an electrical manner.It was also noted that a capacitor was broken off of the pcb, and all six case screws were 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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Manufacturer Narrative
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Failure analysis was performed on the main board.Visual inspection: capacitor missing.Benchtop analysis: powered on device with known good batteries.Device froze on startup.All lcd segments were lit, and the ventricular (v) pace led was lit.The v pace led indicates self-test error, error detected initializing eeprom, detected by function eeprom_initialize.Successfully executed a firmware update using the automated test console.Powered on device to desktop.Ran final functional test on the automated test console.All tests passed.Capacitor broken off the pcb.Conclusion: confirmed customer complaint, device freezes on boot.Failure caused by microprocessor firmware self-test failure.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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