Model Number 186-0106 |
Device Problem
Low Readings (2460)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, the unit had low reading.There was no patient harm associated with this event.
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Manufacturer Narrative
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Evaluation summary: one device was received for evaluation.The sensor passed inspection with no faults found.Device history records report by the manufacturing site showed now issues during the production of this lot.The investigation found the device to function normally.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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