Model Number MS25707 |
Device Problem
No Display/Image (1183)
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Patient Problems
Convulsion, Clonic (2222); Loss of consciousness (2418)
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Event Date 07/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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The investigation has been started but not yet concluded.
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Event Description
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The customer reported that starting at 11pm, the telemetry monitors were "offline" and no longer displayed on the monitor.In addition, recordings were no longer visible even though they were placed in the charging stations.At 4:30 am there was a patient emergency.The patient was not displayed on the monitor and the nurse heard a loud bang.When the nurse came to the patient's room, the patient was found convulsive and unresponsive.The patient required reanimation.
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Manufacturer Narrative
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Additional information was provided stating the patient was in good condition after the event and no further injury was reported.Logs were reviewed and showed offline entries, however were not at the time of the patient event.The patient event was at 4:30 pm on (b)(6) 2017.The logs were reviewed starting at 11pm the night before and the first offline log entry (5:59pm) was almost 90 minutes after the patient event.The cited m300 device was requested to be returned for evaluation however was not provided.A network capture was requested to check for network issues, however was not available for the time of the patient event.Where the cited unit was not returned for evaluation and a network capture was not available at the time of the patient event, root cause could not be determined.There is no indication our device caused or contributed to the patient event.This is an isolated case.
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Event Description
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The customer reported that starting at 11pm, the telemetry monitors were "offline" and no longer displayed on the monitor.In addition, recordings were no longer visible even though they were placed in the charging stations.At 4:30 am there was a patient emergency.The patient was not displayed on the monitor and the nurse heard a loud bang.When the nurse came to the patient's room, the patient was found convulsive and unresponsive.The patient required reanimation.
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Search Alerts/Recalls
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