MAUDE Adverse Event Report: VYAIRE MEDICAL OY VITAL SIGNS¿ PATIENT HYTREL TUBE, ADULT, REUSABLE 900 MM/ 35 IN, CONNECTORS 22/2; ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)

Model Number	MANUAL VENT HOSE, REUSABLE, W BAG ARM
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other ¿ at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not 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
It was reported to vyaire medical that the anesthesiologist had an issue in transferring to manual bag mode during patient use.There was a leak in the breathing system.The bag hose had a pinhole.They had to manually bag the patient until another machine was put in place.Furthermore, there is no harm done to the patient.

• Brand Name: VITAL SIGNS¿ PATIENT HYTREL TUBE, ADULT, REUSABLE 900 MM/ 35 IN, CONNECTORS 22/2
• Common Device Name: ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC)
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; etela-suomen laani; helsinki ; FI
• Manufacturer (Section G): VINCENT MEDICAL (DONGGUAN) MANUFACTURING CO., LTD; 45-46 shabu industrial zone; qiao long district,; dongguan ; CH
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17573780
• Report Number: 3010838917-2023-00072
• Device Sequence Number: 8886513
• Product Code: OFP
• UDI-Device Identifier: 10190752111653
• UDI-Public: (01)10190752111653
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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: MANUAL VENT HOSE, REUSABLE, W BAG ARM
• Device Catalogue Number: 8004515
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown