Model Number 38581 |
Device Problem
Low Readings (2460)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
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Event Description
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The customer reported that the tir-1 thermometer was reading low.No consequences or impact to patient were reported.
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Event Description
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The customer reported that the tir-1 thermometer was reading low.No consequences or impact to patient were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: other text: the returned device was evaluated.External visual inspection found no damage.The device was able to power on using lab stock batteries, obtain measurements and pair with a known good root.Measurements obtained during the initial water bath test were outside the device specification.Microscopic analysis found contamination on the ir sensor lens.This was cleaned and the water bath temperature test was redone.The obtained measurement values remained outside the device specification.A service history record review showed the device has been in the field for over six (6) months with no previously reported issues related to this complaint.
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Search Alerts/Recalls
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