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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, VARIABLE VOLUME OXYGEN RESERVOIR TUBING CARDIOPULMONARY RESUSCITATION AID KIT

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VYAIRE MEDICAL AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, VARIABLE VOLUME OXYGEN RESERVOIR TUBING CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number AIRLIFE¿ PEDIATRIC MANUAL RESUSCITATOR, VARIABLE VOLUME OXYGEN RESERVOIR TUBING
Device Problem Defective Device (2588)
Patient Problem Low Oxygen Saturation (2477)
Event Date 10/02/2019
Event Type  Injury  
Manufacturer Narrative
The customer reported that the product sample is available for analysis. At this time, vyaire has not received the suspect device for evaluation. Any additional information received from the customer will be included in a follow-up report.
 
Event Description
The customer reported that there was no oxygen flow within airlife pediatric manual resuscitator, variable volume oxygen reservoir tubing. The device was attached to the oxygen source but the anesthesiologist cannot hear the oxygen flow. They removed the device from the corrugated tubing, and the customer reported that they were able to hear and feel the oxygen from the end of the tubing. This event occurred while connected to a patient and this lead to poor perfusion. The customer confirmed that no medical intervention was performed to the patient.
 
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Brand NameAIRLIFE PEDIATRIC MANUAL RESUSCITATOR, VARIABLE VOLUME OXYGEN RESERVOIR TUBING
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
Manufacturer (Section G)
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
cerrada via de la produccion
85 industrial mexicali
mexicali, 21397
MX 21397
Manufacturer Contact
stanley tan
22745 savi ranch pkwy
yorba linda, CA 92887
7149193324
MDR Report Key9513447
MDR Text Key179444075
Report Number8030673-2019-00061
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAIRLIFE¿ PEDIATRIC MANUAL RESUSCITATOR, VARIABLE VOLUME OXYGEN RESERVOIR TUBING
Device Catalogue Number2K8018
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2020
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 Unkown

Patient Treatment Data
Date Received: 12/23/2019 Patient Sequence Number: 1
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