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Catalog Number 2K8032 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/06/2017 |
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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Customer reported that "during patient ventilation, patient being ventilated with bag and mask and when intubation is being performed realizing that the mask does not come of the elbow in order to attach to the endotracheal tube.No patient injury, because they changed to another bag".
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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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