MAUDE Adverse Event Report: VYAIRE MEDICAL LIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number	LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Apnea (1720)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the sample used by the patient was discarded in the hospital.In order to have the investigation, they have received an unused reference sample from the hospital.But only the unused sample photos will be investigated.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 that the limb-o¿ single limb anesthesia breathing circuit experienced disconnection with the air filter and circuit after anesthesia with the patient.Later, the patient became pea and took life-saving measures, and noticed that the air filter and circuit had been disconnected again after the heartbeat resumed.As an intervention, when the patient had pea (pulseless electrical activity; it means a cardiopulmonary arrest), a resuscitation was attempted.And then, the cardiopulmonary of the patient has regained.The hospital indicated that the patient may have become apnea due to the disconnection between the circuits.
Additional Manufacturer Narrative
Result of investigation: the pictures sent show the assembly between the cuff and the tube and vyaire technician saw a little mark on the cuff.This little mark is normal and is made by leak tester.Physical sample was not returned for the evaluation, since the sample is needed to perform a dimensional inspection.The defect reported by the customer was not confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LIMB-O SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Common Device Name: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10813944
• Report Number: 8030673-2020-00127
• Device Sequence Number: 11793085
• Product Code: CAI
• UDI-Device Identifier: 10190752122239
• UDI-Public: (01)10190752122239(10)0004112962
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: AFNXXXXX
• Device Lot Number: 0004112962
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention