MAUDE Adverse Event Report: VYAIRE OY AIRLIFE; T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE

Model Number	M1091365VS
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not available for return.A review of the device history record is in progress.All information reasonably known as of 31 oct 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, during an attempt to do positive pressure ventilation (ppv) with t-piece, [the medical provider(s)] could not get pressure high enough to work and deliver properly to the baby.Respiratory therapist x 2 and registered nurse present.Instead used a manual bagger and worked on baby.There was a reported delay in critical care; however, no injury was reported.
Additional Manufacturer Narrative
The actual complaint product was not available for return.The root cause has not been determined.The device history record for lot 24068 was reviewed and the product was produced according to product specifications.All information reasonably known as of 12 dec 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as complaint-(b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, during an attempt to do positive pressure ventilation (ppv) with t-piece, [the medical provider(s)] could not get pressure high enough to work and deliver properly to the baby.Respiratory therapist x 2 and registered nurse present.Instead used a manual bagger and worked on baby.There was a reported delay in critical care; however, no injury was reported.

• Brand Name: AIRLIFE
• Common Device Name: T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE
• Manufacturer (Section D): VYAIRE OY; kuortaneenkatu 2; helsinki, uusimaa FIN-0 0510; FI FIN-00510
• Manufacturer (Section G): VYAIRE OY; kuortaneenkatu 2; helsinki, uusimaa FIN-0 0510; FI FIN-00510
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 20583819
• Report Number: 3010838917-2024-00208
• Device Sequence Number: 8521493
• Product Code: BTL
• UDI-Device Identifier: 10190752135697
• UDI-Public: (01)10190752135697(10)24068(11)240308
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: M1091365VS
• Device Lot Number: 24068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2024
• 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
• Patient Sex: Unknown