MAUDE Adverse Event Report: VYAIRE OY VYAIRE MEDICAL; T-PIECE NEONATAL CIRCUIT

Model Number	M1091335VS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The faulty peep valve could delay therapy to patient while clinician switches them out.This would prevent the patient from getting the proper peep flow, thus interrupting therapy.
Event or Problem Description
Peep valve faulty.3 circuits used on 2 different panda resuscitators would only provide 3 cmh2o of peep despite turning valve higher and higher.  received medwatch report (b)(4).
Additional Manufacturer Narrative
The faulty peep valve could delay therapy to patient while clinician switches them out.This would prevent the patient from getting the proper peep flow, thus interrupting therapy.Supplier informed about the complaint, no further action needed.This is an oem product from mercury medical, hence investigation shall be conducted by the legal manufacturer, task request should be limited to supplier communication.Therefore please reassign it to me as such so that i can perform the task accordingly.
Event or Problem Description
Peep valve faulty.3 circuits used on 2 different panda resuscitators would only provide 3 cmh2o of peep despite turning valve higher and higher.  received medwatch report 0700220000-2023-8422.

• Brand Name: VYAIRE MEDICAL
• Common Device Name: T-PIECE NEONATAL CIRCUIT
• Manufacturer (Section D): VYAIRE OY; kuortaneenkatu 2; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): VYAIRE OY; kuortaneenkatu 2; helsinki uusimaa, fl FIN-0 0510; FI FIN-00510
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18965564
• Report Number: 3010838917-2024-00200
• Device Sequence Number: 20499670
• Product Code: BTL
• UDI-Device Identifier: 10190752135680
• UDI-Public: 10190752135680
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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 Number: M1091335VS
• Device Catalogue Number: M1091335VS
• Device Lot Number: 23207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/23/2024
• Supplement Report FDA Received Date: 04/30/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown