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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE RESUSCITATION, ADULT, WITH MASK, 40 OXYGEN RESERVOIR TUBING, PEEP VALVE CARDIOPULMONARY RESUSCITATION AID KIT

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VYAIRE MEDICAL AIRLIFE RESUSCITATION, ADULT, WITH MASK, 40 OXYGEN RESERVOIR TUBING, PEEP VALVE CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Catalog Number 2K8036
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2018
Event Type  Injury  
Manufacturer Narrative
The reported issue has been identified to be related to a known issue being addressed through a field corrective action. Remediation and repair of the suspect device has been completed and no further investigation is required.
 
Event Description
The customer reported during mock codes, there have been multiple instance where the white cap that covers the monitoring side port on the mechanical resuscitator (ambu-bag) opens. The customer reported this results in effective bagging as ventilator goes through the port rather than to the patient. At this time, it is unknown whether or not there was any patient consequence associated with the event.
 
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Brand NameAIRLIFE RESUSCITATION, ADULT, WITH MASK, 40 OXYGEN RESERVOIR TUBING, PEEP VALVE
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
VYAIRE MEDICAL
26125 north riverwoods blvd
mettawa IL 60045
Manufacturer (Section G)
PRODUCTOS URÓLOGOS DE MÉXICO S.A. DE C.V.
cerradavía dela producción #85
parque undustrial mexicali ii
mexicali, 21397
MX 21397
Manufacturer Contact
mindy faber
26125 north riverwoods blvd
mettawa, IL 60045
8727570116
MDR Report Key7786109
MDR Text Key117206077
Report Number8030673-2018-00012
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 Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8036
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 Received08/24/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unkown
Removal/Correction NumberZ-1571-2018

Patient Treatment Data
Date Received: 08/15/2018 Patient Sequence Number: 1
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