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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC ANES CIRCUIT, ADULT, 75 IN EXP, 3L BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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VYAIRE MEDICAL, INC ANES CIRCUIT, ADULT, 75 IN EXP, 3L BAG CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number A4FX2004
Device Problem Disconnection (1171)
Patient Problem Low Oxygen Saturation (2477)
Event Date 05/31/2017
Event Type  Injury  
Manufacturer Narrative
Investigation results: no physical sample was received for evaluation. However, the dhr for the lot number reported was reviewed and no issues were found related to the disconnection reported. The complete lot was manufactured and released per our internal procedure. In addition, the dhr of the p/n 65-20011 and no issues were identified that could have been involved with the disconnect condition. Since no sample was provided for evaluation, a root cause could not be determined. No corrective actions are indicated at this time. We will continue to track and trend this issue.
 
Manufacturer Narrative
Vyaire has reached out to customer three times to provide the complaint device for further investigation. A ups label was also provided to the customer each time. Unfortunately, vyaire has not received the complaint device for evaluation or the requested additional information. If a sample or any additional information becomes available a follow up emdr will be submitted. (b)(4).
 
Event Description
The customer reported that the circuit itself has been disconnected from the machine. The crna has confidently intubated the patient and we note lack of co2 because the circuit became disconnected. This has resulted in decreased oxygen levels for these patients.
 
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Brand NameANES CIRCUIT, ADULT, 75 IN EXP, 3L 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 Key6681661
MDR Text Key110219784
Report Number8030673-2017-00350
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 company representative,health
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 Received06/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA4FX2004
Device Lot Number0001066957
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2017
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 Initial

Patient Treatment Data
Date Received: 06/30/2017 Patient Sequence Number: 1
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