Catalog Number 5362 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The investigation into this complaint is still in progress at the time of this initial report.
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Event Description
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Customer complaint alleges the mask does not fit tight and as soon as you lift the bag up, the mask falls off.Alleged malfunction reported detected during use.It was reported there was no patient harm.Another mask was obtained for use.
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Manufacturer Narrative
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Qn#: (b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was not returned for evaluation; therefore, the complaint could not be confirmed.
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Event Description
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Customer complaint alleges the mask does not fit tight and as soon as you lift the bag up, the mask falls off.Alleged malfunction reported detected during use.It was reported there was no patient harm.Another mask was obtained for use.
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Search Alerts/Recalls
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