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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. VITAL SIGNS¿; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
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VYAIRE MEDICAL, INC. VITAL SIGNS¿; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Model Number A4UX2044
Device Problems Material Puncture/Hole (1504); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 05/29/2021
Event Type  malfunction  
Event Description
Gases pressure bag on vital signs adult anesthesia breathing circuit has a small hole in the seam at the end of the bag.Staff has reported to me there were others that had the same defect however, none were saved with concurrent item bags to attain lot numbers.The one i am in possession of currently doesn't have the original packaging as well or a lot number on the defective item.Manufacturer response for gases pressure bag for vital signs adult anesthesia breathing circuit, (brand not provided) (per site reporter).Vendor requested we send in the packaging the next time it occurs, replacement product received.
 
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Brand Name
VITAL SIGNS¿
Type of Device
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
VYAIRE MEDICAL, INC.
1100 bird center drive
palm springs CA 92262
MDR Report Key12466664
MDR Text Key271285385
Report Number12466664
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 08/25/2021,08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberA4UX2044
Device Catalogue NumberA4UX2044
Device Lot Number21BJA124EXPO2/23
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/25/2021
Event Location Hospital
Date Report to Manufacturer09/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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