Model Number 865350 |
Device Problems
Device Alarm System (1012); Unexpected Shutdown (4019)
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Patient Problem
Injury (2348)
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Event Date 03/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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Serial number not provided.A follow-up report will be submitted once the investigation is complete.
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Event Description
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The customer alleged a serious injury had occurred when the bedside monitor (mx40) had been shut off.The customer stated that no alerts were programmed to sound when this happens (the device was shut off).The customer stated that the mx40 was being used on a patient for monitoring.The customer reported via medwatch that there was a serious injury of unknown extent or type.
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Manufacturer Narrative
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The device has not been received for evaluation.The root cause of the allegation of failure to alarm is unknown due to insufficient information.The event is considered reportable based on the customer allegation.In the event that the device is returned, the record shall be reopened for further evaluation.
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Search Alerts/Recalls
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