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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL RESUS, PED W/MASK, RESV BAG,; SELF-INFLATING RESUSCITATION BAGS
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VYAIRE MEDICAL RESUS, PED W/MASK, RESV BAG,; SELF-INFLATING RESUSCITATION BAGS Back to Search Results
Catalog Number 2K8020
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2018
Event Type  malfunction  
Manufacturer Narrative
At this time the suspect component is not available for return.Due to the part not being available to be returned, no further evaluation can be completed at this time.
 
Event Description
It was reported to vyaire that the oxygen tubing popped off the reservoir bag while bagging a patient.The customer confirmed that there was no patient harm associated with the reported event.
 
Manufacturer Narrative
Results of investigation: the vyaire quality investigation team received the suspected device/component and performed a failure investigation.The reported issue was confirmed in the laboratory setting.It is considered that personnel could contribute to the reported defect due to if the tube does not have enough solvent or it is not fully inserted into component, the defect reported could occur.The root cause of the reported issue is personnel - operator error - assembly.
 
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Brand Name
RESUS, PED W/MASK, RESV BAG,
Type of Device
SELF-INFLATING RESUSCITATION BAGS
Manufacturer (Section D)
VYAIRE MEDICAL
22745 savi ranch pkwy
yorba linda CA 92887
MDR Report Key8203566
MDR Text Key131769211
Report Number8030673-2018-00021
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2K8020
Was Device Available for Evaluation? No
Date Manufacturer Received02/13/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
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