Catalog Number 8606500 |
Device Problems
Failure to Deliver (2338); No Pressure (2994)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/19/2019 |
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-/ final-report.
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Event Description
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It was reported that the display of the device froze during ventilation.The user reportedly turned the device off and on, but the device could not start anymore.There was no patient injury reported.
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Manufacturer Narrative
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After the case in question, a fse replaced the pcb which controls display and user interface.The replaced pcb was analyzed in the manufacturer¿s lab and no indications for a malfunction were found.A long-time run was performed and a new logfile was taken and no errors or failures were found either.Therefore, the exact root cause for the reported symptom could not be determined.In case of a frozen monitor integrated monitoring and selection of parameters/ modes is not possible any more.During automatic ventilation an automatic shutdown of the ventilation mode and switch to the man/ spont mode will be done.An alarm will be given via the secondary piezo signal generator of the power supply.
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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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