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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ANES CIRCUIT, 90 IN EXP, 1L BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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VYAIRE MEDICAL, INC ANES CIRCUIT, 90 IN EXP, 1L BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number B1734XX4
Device Problem Occlusion Within Device (1423)
Patient Problem Low Oxygen Saturation (2477)
Event Date 06/15/2017
Event Type  Injury  
Manufacturer Narrative
Investigation results: one opened sample was received for evaluation. The sample was inspected and a leak test was performed. The sample failed the leak test in the wye component p/n r5160ya, after performing further evaluation it was detected that the wye was broken. The dhr was reviewed for the lot number reported, and no issues were found that may have contributed to the reported issue. Two years of complaints were reviewed and no adverse trend was detected. Based on the investigation, it is possible that the wye was misaligned while it was being assembled by the press and this created the crack condition in the wye. To correct this issue, the assembly personnel were notified and retrained on the procedure regarding the equipment press.
 
Manufacturer Narrative
Vyaire has received the complaint device and has finished the required decontamination procedure. The sample has been shipped to the manufacturing plant for further analysis. A follow up mdr will be sent once the investigation has been completed.
 
Event Description
Customer reported that the "circuit passed pressure test on ge anesthesia machine. Patient started to desat, they put on new circuit and everything was ok. There was a flap in the area of the wye between the 2 hoses. Product was used on patient, no patient harm. ".
 
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Brand NameANES CIRCUIT, 90 IN EXP, 1L BAG
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
VYAIRE MEDICAL, INC
cerrada vía de la producción
no.85 parque industrial
mexicali baja california norte
MX
Manufacturer (Section G)
VYAIRE MEDICAL, INC
cerrada vía de la producción
parque industrial mex
mexicali baja california norte
MX
Manufacturer Contact
mindy faber
26125 n. riverwoods blvd
mettawa, IL 60045
MDR Report Key6708014
MDR Text Key258950992
Report Number8030673-2017-00352
Device Sequence Number1
Product Code CAI
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
Type of Report Initial,Followup
Report Date 10/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberB1734XX4
Device Lot Number0001039746
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/12/2017 Patient Sequence Number: 1
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