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U.S. Department of Health and Human Services

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

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CAREFUSION AIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number 2K8004
Device Problems Defective Device (2588); No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2020
Event Type  Injury  
Manufacturer Narrative
Vyaire medical has received the defective component and results are pending completion of investigation.
 
Event Description
The customer reported while using the airlife adult manual resuscitator, an inability to ventilate. On (b)(6) 2020, the customer reported (b)(6) year old female from nursing home brought in due to choking airway cleared and was intubated (food visible below vocal cords). After exchanging the bags (manual resuscitator), the customer reported alternative ventilation was provided to the patient.
 
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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)
CAREFUSION
vernon hills
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 Key9946542
MDR Text Key188825110
Report Number8030673-2020-00092
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 Nurse Practitioner
Type of Report Initial,Followup
Report Date 03/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2K8004
Device Catalogue Number2K8004
Device Lot Number0000416682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2020
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 Initial

Patient Treatment Data
Date Received: 04/09/2020 Patient Sequence Number: 1
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