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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT

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VYAIRE MEDICAL, INC RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Catalog Number 2K8032
Device Problem Failure to Disconnect (2541)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device. Customer advocacy is still waiting for additional information regarding reported issue. If a sample or any additional information becomes available a follow up emdr will be submitted.
 
Event Description
Customer reported "face mask is hard to detach from resuscitator bag. Item was used on patient and disposed immediately". "during beside intubation, nurses on duty opened the "ambu-bag" and tried to detach the face ask from the resuscitator bag but to no avail. The connector and the face mask were firmly set together as opposed to the usual working order of an "ambu-bag". This resulted into a slight delay in delivering oxygen for the patient".
 
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Brand NameRESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
VYAIRE MEDICAL, INC
cerrada via de la produccion
no. 85 parque industrial
mexicali baja california norte
MX
Manufacturer (Section G)
VYAIRE MEDICAL, INC
cerrada via de la produccion
no. 85 parque industrial
mexicali baja california norte
MX
Manufacturer Contact
mindy faber
26125 north riverwoods blvd
mettawa, IL 60045
MDR Report Key7041856
MDR Text Key92343406
Report Number8030673-2017-00381
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8032
Device Lot Number0001070054
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2017
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 Treatment Data
Date Received: 11/17/2017 Patient Sequence Number: 1
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