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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
Device Problem Suction Failure (4039)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4): 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.
 
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
Type of Device
ANAESTHESIA BREATHING CIRCUIT, SINGLE-USE
MDR Report Key11962945
MDR Text Key255179652
Report Number8030673-2021-00171
Device Sequence Number1
Product Code BTM
UDI-Device Identifier10190752125155
UDI-Public(01)10190752125155(10)0004183134
Combination Product (y/n)N
PMA/PMN Number
EXEMPTED
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 05/13/2021
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Model NumberLIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Device Catalogue NumberGK7FXXXX
Device Lot Number0004183134
Was Device Available for Evaluation? Yes
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 Sequence Number1
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