Model Number EMU40 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022); Data Problem (3196)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device arrived on august 9th, 2016.Natus will conduct an investigation and report to fda with a follow up report.Device returned on aug/09.
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Event Description
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The device was hot to the touch and lost hours of recording.No one was injured.
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Manufacturer Narrative
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The reported device has been returned, and upon investigation, natus could not reproduce the overheating issue.The device did not exhibit any sign of burn, and it performed to specification without any issue.
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Event Description
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The device was hot to the touch and lost hours of recording.No one was injured.
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Search Alerts/Recalls
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