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Catalog Number 2K8005 |
Device Problem
Failure to Disconnect (2541)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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It has been confirmed by carefusion/bd that the complaint sample is not available for evaluation.Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device.If a sample or any additional information becomes available a follow up emdr will be submitted.(b)(4).
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Event Description
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The customer reported the following information.¿the other complaints were given to me verbally and were all the same; they could not get the mask off of the bag easily to attach to the ett upon intubation.I do not have exact dates, exact patients, or any of the bags.Basically, staff has had issues and are not happy when it is difficult to get the masks off.This happens in emergency situations.When a mask cannot be removed, this is delaying treatment to a patient who needs to be ventilated.¿.
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Manufacturer Narrative
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Follow up submission: no sample was provided for evaluation.At this time we are unable to confirm the reported issue.However, based on similar complaint investigations, a probable root cause is related to the current mirror finish surface on the elbow, which makes the mask very difficult to remove.Capa was opened to further investigate this issue.Capa (b)(4).The elbow will now contain a textured finish to allow the mask to be easily removed from the elbow.
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Search Alerts/Recalls
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