Catalog Number 8411740 |
Device Problems
Premature Discharge of Battery (1057); Gas Output Problem (1266); Decrease in Pressure (1490); Failure to Deliver (2338); Complete Loss of Power (4015)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The investigation has just started; results will be provided in a follow-up report.
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Event Description
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It was reported that there was a battery failure.When the device was unplugged, it immediately shut down.After replacing the battery, the device was in good working order.There was no patient injury reported.
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Event Description
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It was reported that there was a battery failure.When the device was unplugged, it immediately shut down.After replacing the battery, the device was in good working order.There was no patient injury reported.
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Manufacturer Narrative
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The investigation was based on the description of event as only available information.There was no log file available for further investigation at the manufacturer¿s site.As reported a faulty internal battery was identified as root cause of the event.In case of a failure of the mains power supply and without external batteries, the device switches over to dc operation on internal batteries without interrupting the ventilation.The device alarms different levels of depletion of the internal batteries with corresponding priority.If the internal batteries are depleted the device shuts down with audible power failure alarm.In this case the emergency-breathing valve opens to allow spontaneous breathing of the patient.When mains is re-connected again the device starts with a warm start with the same settings as before and continuous to ventilate the patient.Replacing the internal battery remedied the issue.There were no patient health consequences reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
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Search Alerts/Recalls
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