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U.S. Department of Health and Human Services

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

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VYAIRE MEDICAL AIRLIFE MANUAL RESUSCITATOR VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number AIRLIFE¿ MANUAL RESUSCITATOR VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2020
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
The customer reported that the tube of airlife adult manual resuscitator, variable volume oxygen reservoir tubing, adult mask comes out and cannot be reattached. The issue occurred during patient-use and the customer confirmed that there was no patient harm associated with this reported event.
 
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Brand NameAIRLIFE MANUAL RESUSCITATOR VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK
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 vía de la producción
85 parque undustrial mex iii
mexicali, 21397
MX 21397
Manufacturer Contact
mindy faber
26125 n. riverwoods blvd.
mettawa, il 
7570116
MDR Report Key10292953
MDR Text Key201868069
Report Number8030673-2020-00111
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAIRLIFE¿ MANUAL RESUSCITATOR VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK
Device Catalogue Number2K8017
Device Lot Number0004068224
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2020
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 Initial

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