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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE
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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
Medical Device Problem Code Suction Problem (2170)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/10/2021
Type of Reportable Event Malfunction
Additional 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 or Problem 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.
 
Additional Manufacturer Narrative
Result of investigation: pictures and sample received for investigation.A visual inspection was performed observing that the unit has an incorrect yankuer.Therefore the defect reported by the customer was confirmed.
 
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Brand Name
LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Common Device Name
ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE
MDR Report Key11962944
Report Number8030673-2021-00172
Device Sequence Number3663970
Product Code BTM
UDI-Device Identifier10190752125155
UDI-Public(01)10190752125155(10)0004183134
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPTED
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 05/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
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
Initial Date Received by Manufacturer 05/13/2021
Supplement Date Received by Manufacturer07/05/2021
Initial Report FDA Received Date06/08/2021
Supplement Report FDA Received Date07/29/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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