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

Catalog Number 2K8005

Device Problem Misassembled (1398)

Patient Problem Death (1802)

Event Date 04/27/2017

Event Type  Death  

Manufacturer Narrative

Vyaire medial has reached out to the customer multiple times to obtain the impacted device and additional information.At this time the customer has responded stating they have the device quarantined and "that they cannot release the defective product due to the severity of the situation".Vyaire is attempting to evaluate the impacted device on site.Vyaire is still waiting for the customers response if they will be willing to allow an onsite inspection of the impacted device.If a device or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

Customer reported that "the resuscitation bag did not inflate/deflate while in patient use.The patient died.The valve in the rear of the device was folded over and allowed air to escape through the back as the device was squeezed.The clinical story is basically that the patient needed intubation, they connected the resuscitation bag and there was no chest rise.They verified intubation and re-intubated the patient with a glidescope and tube placement was verified that way.Still no chest rise and they tried other things and finally switched out the resuscitation bag.The patient in the meantime coded and died.Customer has stated that they have filed a medwatch the number has not been reported to vyaire at this time.

Manufacturer Narrative

Device evaluation: on august 17, 2017, the product engineering director and vyaire¿s outside legal counsel visually inspected the resuscitation bag at temecula valley hospital.This complaint will be closed pending legal counsel involvement.If any additional information becomes available the complaint will be re-opened to include that information as appropriate.

• 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, IL 60045
• MDR Report Key: 6603172
• MDR Text Key: 76371248
• Report Number: 8030673-2017-00338
• 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: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• 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: 0001040664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death