Model Number 15 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Physio-control evaluated the customer¿s device and verified the reported issue.Physio replaced the system pcb assembly.Thereafter, proper device operation was observed through functional and performance testing and the device was returned to the customer for use.
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Event Description
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The customer contacted physio-control to report that when attempting to power on their device it locked up at the self-test screen and would not complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
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Manufacturer Narrative
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Physio-control further evaluated the removed system pcb assembly and determined that the cause of the reported issue was that the single board computer (sbc) portion of the assembly was inoperative.
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Event Description
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The customer contacted physio-control to report that when attempting to power on their device it locked up at the self-test screen and would not complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
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Search Alerts/Recalls
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