VYAIRE MEDICAL, INC RESUS, ADLT W/MASK, 40" TBG, 6/CS; CARDIOPULMONARY RESUSCITATION AID KIT
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Catalog Number 2K8005 |
Device Problem
Failure to Disconnect (2541)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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Carefusion has reached out to the customer to obtain sample for investigation.Ups label was provided to the customer.At this time, carefusion has not received the suspect device.If the device is returned, an investigation will be performed, and a supplemental report will be submitted.(b)(4).
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Event Description
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The customer reported that while using the adult resuscitation device, "the elbow wouldn't separate from the mask.They were able to resuscitate using the same resuscitation bag in and upright vertical position if they removed the elbow or through the mask, as the 15mm connection to mate to the endotracheal tube had enough clearance to pass through and seal.No patient/caregiver injury/death.".
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Manufacturer Narrative
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One opened sample was returned for further evaluation.A visual inspection was performed and it was observed that the sample did not exhibit the textured surface finish on the connectors outer diameter.The textured surface makes it easier to detach the mask form the elbow.The prior design had a smooth mirror finish as exhibited on this sample.It was found that this mirror finish on the elbow and the smooth finish on the mask can create a vacuum effect making the removal of the mask difficult.A design change has been made to this product adding the texturized surface to the elbow eliminating the difficult remove failure mode.
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Search Alerts/Recalls
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