MAUDE Adverse Event Report: VYAIRE MEDICAL, INC RESUS, ADLT W/MASK, 40" TBG, 6/CS; CARDIOPULMONARY RESUSCITATION AID KIT

Catalog Number 2K8005

Device Problem Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2017

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

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.".

Manufacturer Narrative

Unfortunately the device was not returned for further evaluation.However the reported lot number has been identified as a recalled lot for a known issue.The prior design had a smooth mirror finish.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.

• Brand Name: RESUS, ADLT W/MASK, 40" TBG, 6/CS
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): VYAIRE MEDICAL, INC; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte ; MX
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada vía de la producción; no.85 parque industrial; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd; mettawa, CA 60045
• MDR Report Key: 6616906
• MDR Text Key: 76820992
• Report Number: 8030673-2017-00339
• Device Sequence Number: 1
• Product Code: OEV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2K8005
• Device Lot Number: 0001014036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention