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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, ADULT MASK, 7' O2 VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

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VYAIRE MEDICAL AIRLIFE ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, ADULT MASK, 7' O2 VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Model Number AIRLIFE¿ ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, ADULT MASK, 7' O2
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 was received.
 
Event Description
The customer reported that after successfully intubating the patient in the cardio-thoracic icu, the team was unable to separate the mask from the resuscitation bag of airlife adult manual resuscitator to ventilate via the endotracheal tube. The team was able to resume ventilation and oxygenation with a new resuscitation bag. At this time, patient outcome is unknown.
 
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Brand NameAIRLIFE ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, ADULT MASK, 7' O2
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
Manufacturer (Section G)
GALEMED XIAMEN CO LTD
amoy export processing zone 39
section 3, haijing east road
fujian province, 36102 6
CH 361026
Manufacturer Contact
mindy faber
26125 n. riverwoods blvd.
mettawa, il 
MDR Report Key10029512
MDR Text Key192149813
Report Number3006783791-2020-00001
Device Sequence Number1
Product Code BTM
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 Other Health Care Professional
Type of Report Initial
Report Date 04/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAIRLIFE¿ ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, ADULT MASK, 7' O2
Device Catalogue Number2K7000
Device Lot Number0004093435
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/06/2020 Patient Sequence Number: 1
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