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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 Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2020
Event Type  Injury  
Manufacturer Narrative
At this time, vyaire has not received the suspect device/component for evaluation. Therefore, no root cause could be determined yet. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
 
Event Description
The customer reported that following intubation, one of the two vital signs adult anesthesia breathing circuit, attachment pieces that provide air exchange and oxygenation had a malfunctioned due to a plastic piece covering the entirety of the air exchange circuit filter. This prevented any air exchange from happening. This resulted in the patient not receiving oxygenation, requiring manual ventilation to be used until it was replaced with a new circuit. At this time, there is no information regarding patient harm associated with the reported event.
 
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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 vía de la producción
no. 85, parque undustrial mex
mexicali, 21397
MX 21397
Manufacturer Contact
mindy faber
26125 n. riverwoods blvd.
mettawa, il 
MDR Report Key10261392
MDR Text Key203094592
Report Number8030673-2020-00102
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 Received07/10/2020
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2020
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: 07/10/2020 Patient Sequence Number: 1
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