Model Number MS25510 |
Device Problem
Device Alarm System (1012)
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Patient Problem
Apnea (1720)
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Event Date 07/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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The investigation has been started but not yet concluded.The investigation result will be reported in the follow up report.
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Event Description
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It was reported that a patient came out of surgery fully awake and breathing on their own from surgery.At around 3 pm the patient stopped breathing and the nursing staff alleges that there was no alarm.It is suspected that the patient did not breath for.
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Manufacturer Narrative
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The iacs logs and patient profile were reviewed and the cited iacs was tested for functionality.The logs showed that between 14:55 and 15:07:45 there were multiple alarms generated for spo2 less than 90.An audio pause was seen at 15:07:23 after an spo2 alarm.It was found that the apnea alarm threshold was not breached during this time period.At 15:07:39, it was found that an alarm generated for low respiration.An apnea alarm was then confirmed to have generated at 15:07:45.This was shortly after the audio pause was initiated.Two more apnea alarms and audio pause events were seen shortly after this.From the patient profile, it could be found that the default alarm volume for the cockpit was 10% on this device.It was found that the cockpit touchscreen was not pressed from 13:30 until 15:11 after the event.The device from the event was tested for functionality by a draeger service technician.It was found that the apnea alarm was generated both audibly and visually when the alarm limit was breached.It was determined that there was no failure with the device.The necessary alarms generated when expected.
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Event Description
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Please refer to the initial report.
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Search Alerts/Recalls
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