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Catalog Number 2K8005 |
Device Problem
Failure to Disconnect (2541)
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Patient Problem
Hypoxia (1918)
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Event Date 02/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) has reached out to customer three times to provide the complaint device for further investigation.A (b)(6) label was also provided to the customer each time.Unfortunately, (b)(4) has not received the complaint device for evaluation or the requested additional information.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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Customer reported the following "we have also heard other scenarios when a patient was brought in intubated, a new bag/mask (always attached in the bag) was opened and they were unable to provide ventilation/oxygenation.There was a delay until another bag could be retrieved or the mask was dislodged by someone.".
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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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