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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 Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/11/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). It has been confirmed by the medwatch that the complaint sample is not available for evaluation. An attempt has been made by vyaire to gain additional information and a representative sample from the same lot number from the customer. Vyaire is still waiting for additional information regarding reported issue. If a sample or any additional information becomes available after all due diligence attempts have been completed a follow up emdr will be submitted.
 
Event Description
Per medwatch report (b)(4). Could not feel or hear oxygen through bag/valve mask. Attempted to use bag/valve mask on patient and even with good seal and chest rise the patients o2 sats would not improve, noticed that we could not feel the oxygen flow or hear it through the bag/valve mask. This occurred during general anesthesia for repair of a left popliteal artery. Hospital provided patient identifier (b)(6).
 
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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
22745 savi ranch parkway
yorba linda CA 92887
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 Key7075339
MDR Text Key93496472
Report Number8030673-2017-00391
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,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Device Lot Number001086128
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 Received11/27/2017
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: 12/01/2017 Patient Sequence Number: 1
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