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

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 321462959
• Report Number: 3010838917-2023-00072
• Device Sequence Number: 1
• Product Code: OFP
• UDI-Device Identifier: 10190752111653
• UDI-Public: (01)10190752111653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention