Model Number 4415 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/19/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint is related to (b)(4)/ medwatch # 1828100-2016-00781.
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Event Description
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It was reported that during the use of the device for a non-clinical activity, the unit was failing electrical safety test.There was no patient involvement.The issue was discovered when the unit was repaired in the field.
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Manufacturer Narrative
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The field service representative (fsr) verified the issue.After allowing the unit to dry out he fully tested the heater cooler (tcm) and it was working fine.The unit operated to manufacturer¿s specifications.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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