Model Number 8210 |
Device Problem
Contamination (1120)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
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Event Description
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It was reported that there were issues due to fluid ingress for these 8210 devices."while they were working they began to put aside modules with corrosion and lamination issues with the keypads." customer confirmed no patient involvement.
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Manufacturer Narrative
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Correction: please disregard file.After further review, the file is now deemed as non-reportable malfunction.
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Event Description
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It was reported that there were corrosion and lamination issues noted on their 8210 (oximetry) devices."while they were working they began to put aside modules with corrosion and lamination issues with the keypads." customer confirmed no patient involvement.
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Search Alerts/Recalls
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