Model Number 980 |
Device Problems
Device Alarm System (1012); Defective Alarm (1014)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that a 980 ventilator graphical user interface (gui) audio failed.The ventilator was not in use on a patient at the time of the reported event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Device evaluation summary: the service engineer (se) inspected the device and found the graphical user interface (gui) audio buzzer not working.The se determined the part needs to be replaced.Further service actions and outcomes have not been detailed at this time.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction to evaluation codes result.Device evaluation summary: the service engineer (se) inspected the device and replaced the speaker, exhalation valve and the graphical user interface printed circuit board assembly (pcba).The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If the replaced parts are returned for failure investigation, a supplemental medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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