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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) CARDIOPULMONARY RESUSCITATION AID KIT

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VYAIRE MEDICAL AIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number AIRLIFE¿ ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M
Device Problem Mechanical Problem (1384)
Patient Problem Low Oxygen Saturation (2477)
Event Date 03/12/2021
Event Type  Injury  
Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation. No root cause has 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 airlife¿ adult manual resuscitator, 40'' (1. 0m) oxygen reservoir tubing, adult mask experienced patient ambu bag was not seeming to fill with air or there was no resisting of the bag. Patient o2 saturation dropped. As an intervention, different ambu bag was used.
 
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Brand NameAIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M)
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 v?a de la producci?n
no. 85, parque undustrial mex
mexicali, 21397
MX 21397
Manufacturer Contact
peter sparacio
26125 n. riverwoods blvd.
mettawa, IL 60045
8333273284
MDR Report Key11780670
MDR Text Key258437055
Report Number8030673-2021-00162
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
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 Number2K8005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2021
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 Initial

Patient Treatment Data
Date Received: 05/05/2021 Patient Sequence Number: 1
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