MAUDE Adverse Event Report: VYAIRE OY VYAIRE MEDICAL OY; MULTI ABSORBER EF, DISPOSABLE CIRCUITS

Model Number	M1173311
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 03 jul 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
Sun med holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different units.This is the second of three reports.Refer to 3010838917-2024-00202 for the first report.Refer to 3010838917-2024-00204 for the third report.It was reported, [it was observed] leaking and failure of the product to remove carbon dioxide (co2) from the circuit.There was no reported injury.Additional information received on 20jun2024 reported, the fico2 read 5; the canister was replaced; there was no reported injury.

• Brand Name: VYAIRE MEDICAL OY
• Common Device Name: MULTI ABSORBER EF, DISPOSABLE CIRCUITS
• 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: 19672013
• Report Number: 3010838917-2024-00203
• Device Sequence Number: 6578532
• Product Code: CBL
• UDI-Device Identifier: 10190752184336
• UDI-Public: 10190752184336
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: M1173311
• Device Catalogue Number: M1173311
• Device Lot Number: L01A-01975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown