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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL LIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE

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VYAIRE MEDICAL LIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE Back to Search Results
Model Number LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Device Problem Suction Problem (2170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
Event Type  malfunction  
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 2 (two) different incidents for vented yankauer and non-vented yankauer. The customer reported that the limb-o¿ single limb anesthesia breathing circuit experienced a suction problem and secretion issues while suctioning the patient. The customer confirmed that there was no patient harm associated with the reported event.
 
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Brand NameLIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Type of DeviceANAESTHESIA BREATHING CIRCUIT, SINGLE-USE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa IL 60045
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
erika bonilla
510 technology dr,
irvine, CA 92618
7149227837
MDR Report Key11962944
MDR Text Key258436229
Report Number8030673-2021-00172
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPTED
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Device Catalogue NumberGK7FXXXX
Device Lot Number0004183134
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2021
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

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