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U.S. Department of Health and Human Services

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

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VYAIRE MEDICAL AIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number AIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M
Device Problem Material Twisted/Bent (2981)
Patient Problem Hypoxia (1918)
Event Date 01/30/2020
Event Type  Injury  
Manufacturer Narrative
As of this time, no sample has been returned. There are three(3) lot numbers available for this sample: 0004118094, 0004111662 and 0004095580. Any additional information received from the customer will be included in a follow-up report.
 
Event Description
The customer reported that the airlife adult manual resuscitator experienced a defect problem. In post anesthesia care unit, patient experienced difficulty breathing. So they bagged the patient to continue breathing. But due to hose at base of ambu bag was kinked or pinched, it did not allow adequate oxygen to flow into the ambu bag. When the issue occurred, the patient's spo2 were not coming up from low 80%, once identified staff were able to get line open enough to bring patient's spo2 up to 99%.
 
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Brand NameAIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
Manufacturer (Section G)
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
cerrada vía de la producción
85 parque undustrial mex iii
mexicali, 21397
MX 21397
Manufacturer Contact
mindy faber
26125 n. riverwoods blvd.
mettawa, IL 60045
MDR Report Key9777287
MDR Text Key188824107
Report Number8030673-2020-00079
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M
Device Catalogue Number2K8004
Device Lot Number0004118094, 0004111662
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/02/2020 Patient Sequence Number: 1
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