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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. AIRLIFE CARDIOPULMONARY RESUSCITATION AID KIT

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VYAIRE MEDICAL, INC. AIRLIFE CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number 2K8038
Device Problem Disconnection (1171)
Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)
Event Date 02/25/2020
Event Type  malfunction  
Event Description
Neonatal resuscitator bag (ambu/bvm [bag valve mask]) used to ventilate patient in the emergency department during intubation had a manufacturer's defect where the high pressure o2 tubing became disconnected inside the large bore tubing where it cannot be reconnected. Discovered when patient's heart rate and spo2 fell during intubation attempt and did not recover with manual resuscitation. Spo2 fell into the teens and hr fell to the 50s. Compressions done approximately 1 minute. Resuscitator bag was still connected to 100% fio2 at 15lpm. However, high pressure tube had been disconnected at resuscitator bag. Upon discovery, quickly changed to pediatric resuscitator bag which was also at bedside. Patient's hr and spo2 recovered immediately.
 
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Brand NameAIRLIFE
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
VYAIRE MEDICAL, INC.
26125 north riverwoods blvd
mettawa IL 60045
MDR Report Key9959248
MDR Text Key187616496
Report Number9959248
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/10/2020,04/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2K8038
Device Catalogue Number2K8038
Device Lot Number0004020711
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/10/2020
Event Location Hospital
Date Report to Manufacturer04/14/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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