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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE INFANT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING CARDIOPULMONARY RESUSCITATION AID KIT

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VYAIRE MEDICAL AIRLIFE INFANT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number AIRLIFE¿ INFANT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING
Device Problem Disconnection (1171)
Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)
Event Date 02/01/2020
Event Type  Injury  
Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation. Therefore, root cause has not been determined yet. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
It was reported to vyaire medical that the neonatal resuscitator bag used to ventilate patient in the emergency department during intubation had a manufacturer's defect where the high pressure o2 tubing disconnected inside the large bore tubing. This event occurred while connected to a premature patient and this lead to desaturation and bradycardia, compression initiated for one minute and the patient was transferred to another pediatric resuscitator bag and the patient's heart rate and spo2 back to normal.
 
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Brand NameAIRLIFE INFANT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
Manufacturer (Section G)
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
cerrada v?a de la producci?n
85 parque undustrial mex iii
mexicali, 21397
MX 21397
Manufacturer Contact
mindy faber
26125 n. riverwoods blvd.
mettawa, il 
MDR Report Key10058079
MDR Text Key194474341
Report Number8030673-2020-00096
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAIRLIFE¿ INFANT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING
Device Catalogue Number2K8038
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/14/2020 Patient Sequence Number: 1
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