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U.S. Department of Health and Human Services

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

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VYAIRE MEDICAL, INC RESUS, ADLT W/MASK, 40" TBG, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
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
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.
 
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. ".
 
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Brand NameRESUS, ADLT W/MASK, 40" TBG, 6/CS
Type of DeviceCARDIOPULMONARY 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 Key6616965
MDR Text Key113290910
Report Number8030673-2017-00340
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
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 Received06/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Device Lot Number0001014036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/06/2017 Patient Sequence Number: 1
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