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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 Misassembled (1398)
Patient Problem Death (1802)
Event Date 04/27/2017
Event Type  Death  
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.
 
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.
 
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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 Key6603172
MDR Text Key106053188
Report Number8030673-2017-00338
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 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 Received05/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Device Lot Number0001040664
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/21/2017
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 Treatment Data
Date Received: 05/31/2017 Patient Sequence Number: 1
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