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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL (S)SUB MASK/SIZE 5/ADULT ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE

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VYAIRE MEDICAL (S)SUB MASK/SIZE 5/ADULT ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE Back to Search Results
Model Number (S)SUB MASK/SIZE 5/ADULT
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2021
Event Type  Injury  
Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation. No root cause has been 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 the limb-o¿ single limb anesthesia breathing circuit experienced very deflated which makes it difficult to get a quality seal to mask ventilate patients. As an intervention, anesthesia technicians manually inflate the mask via the tail valve using a syringe. The customer confirmed that there was no patient harm associated with the reported event.
 
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Brand Name(S)SUB MASK/SIZE 5/ADULT
Type of DeviceANAESTHESIA BREATHING CIRCUIT, SINGLE-USE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key11815474
MDR Text Key250315337
Report Number8030673-2021-00166
Device Sequence Number1
Product Code CAI
UDI-Device Identifier10190752121867
UDI-Public(01)10190752121867(10)1223361
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 04/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number(S)SUB MASK/SIZE 5/ADULT
Device Catalogue NumberAFN580AC
Device Lot Number1223361
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated by Manufacturer? Yes
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: 05/12/2021 Patient Sequence Number: 1
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