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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

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VYAIRE MEDICAL ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Model Number ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2020
Event Type  Injury  
Manufacturer Narrative
As of this time, has been shipped for investigation. However, the customer confirmed that the sample is available. As an intervention, an ambu bag was required to be used until it was replaced with a new circuit. Any additional information received from the customer will be included in a follow-up report.
 
Event Description
The customer reported that the adu520x4d vital signs adult anesthesia breathing circuit experienced circuit malfunction due to plastic piece covering the air exchange circuit filter during use. The customer confirmed that there was no patient harm associated with this reported event. As an intervention, a manual ventilation was required to be used until it was replaced with a new circuit.
 
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Brand NameANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
Manufacturer (Section G)
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
cerrada v[?]a de la producci[?]n
no. 85, parque undustrial mex
mexicali, 21397
MX 21397
Manufacturer Contact
mindy faber
26125 n. riverwoods blvd.
mettawa, il 
MDR Report Key10268596
MDR Text Key203102344
Report Number8030673-2020-00103
Device Sequence Number1
Product Code BTM
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 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG
Device Catalogue NumberADU520X4D
Device Lot Number0004143192
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/13/2020 Patient Sequence Number: 1
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