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Model Number V200 |
Device Problems
Device Alarm System (1012); Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: (b)(6) 2018.Date of report: 13sep2019.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.The customer was sent an exhalation filter and an oxygen flow sensor which were replaced.The customer performed testing and the issue was resolved.The ventilator was returned to use.
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Event Description
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It was reported that the ventilator generated an exhalation valve test failure error code, an oxygen flow accuracy error code, and a relief valve cracking pressure out of range error code.No patient harm reported.
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Search Alerts/Recalls
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