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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 Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2017
Event Type  Injury  
Manufacturer Narrative
Follow up submission: three opened samples were received and inspected. All of the samples were found with a deformation of the large dark blue bag component and 1 of the samples failed the leak test. The samples were returned by the customer not in their original package. A dhr review was completed and no issues were found during the manufacturing process that may have contributed to this reported condition. 2-years of complaints were reviewed and no trend was detected related to this issue. The manufacturing processes were reviewed and no issues were observed that would contribute to the deformed condition. In addition, the product label warns about permanent distortion if the resuscitator bag is stored in a compressed state, the packaging method also indicates the correct way to package the product prior to shipment to the customer. The deformed condition could be related to an incorrect storage out of the vyaire medical plant. Our current process states proper methods to handle and store the finished good to prevent damage tot he product. No corrective actions are indicated for this reported issue.
 
Manufacturer Narrative
Carefusion has received the complaint device and is currently performing an investigation into the reported issue. A follow up mdr will be sent once the investigation has been completed. (b)(4).
 
Event Description
Customer reported that the "paramedics were providing resuscitation to a patient. The 2k8005 bag was pulled out to use on the patient. It seemed deformed on the blue part of the bag where you squeeze to provide ventilation. When attached to oxygen, the bag would not inflate and could not be used.
 
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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 Key6586500
MDR Text Key208509594
Report Number8030673-2017-00336
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
Type of Report Initial,Followup
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Device Lot Number0001010334
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2017
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: 05/23/2017 Patient Sequence Number: 1
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