Model Number 802100 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) observed the ccm to continuously reboot when powered on.It was determined that the flat panel interface node controller (fpinc) printed circuit board (pcb) was the cause of the problem.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Event Description
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The product surveillance technician (pst) reported that during routine testing of the device at service center, the central control monitor (ccm) kept rebooting.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.It was determined that the single board computer (sbc) printed circuit board assembly (pcba) was the cause of the problem.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Search Alerts/Recalls
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