Model Number 08H67-01 |
Device Problem
Smoking (1585)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation is in process.A follow up report will be submitted when the evaluation is complete.
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Event Description
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The customer reported the failure of a cell dyn ruby after repeated power outages associated with a storm and lightening.The customer stated fire/visible smoke was observed from the instrument.There was no report of injury.There was no reported impact to patient management.
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Manufacturer Narrative
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A subsequent site visit by the field service engineer (fse) for analyzer (sn#: (b)(6)occurred post repeated power outages associated with an electrical storm.The motor board and the accessories peripheral ports were replaced by the fse which resolved the issue.A review of the service history for the cell-dyn ruby analyzer revealed no additional issues were reported.A review of tracking and trending did not identify any trends for the cell-dyn ruby.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Labeling was reviewed and contains adequate information on troubleshooting, removal and installation of the part.The evidence of fire was limited to the board and the peripheral ports and did not spread to other parts of the instrument.Based on the investigation, no product deficiency was identified.
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Event Description
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The customer reported the failure of a cell dyn ruby after repeated power outages associated with a storm and lightening.The customer stated fire/visible smoke was observed from the instrument.There was no report of injury.There was no reported impact to patient management.
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Search Alerts/Recalls
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