MAUDE Adverse Event Report: VYAIRE OY VYAIRE OY; MEDISORB, MULTI ABSORBER ORIGINAL

Model Number	M1173310
Medical Device Problem Code	No Pressure (2994)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
System could not pressurize.
Additional Manufacturer Narrative
The system is not able to pressurize and would cause a delay in the patient's treatment of therapy.
Event or Problem Description
System could not pressurize.
Additional Manufacturer Narrative
The system is not able to pressurize and would cause a delay in the patient's treatment of therapy.Customer complained about "not working properly/broken-wont pass morning check out".Defective canister was disposed, no sample, no photos provided.Failure mode cannot be confirmed.Root cause cannot be determined.Reviewed sha - rmf-hl-0053 - co2 absorption products and components - mdd - rev07 - 12-dec-2023.I concluded that closest risk id could be: sha-hl-0053-044; hazard category: manufacturing, packaging or shipping problem.

• Brand Name: VYAIRE OY
• Common Device Name: MEDISORB, MULTI ABSORBER ORIGINAL
• 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: 19000960
• Report Number: 3010838917-2024-00201
• Device Sequence Number: 19595911
• Product Code: CBL
• UDI-Device Identifier: 10190752184329
• UDI-Public: 10190752184329
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/27/2024

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: M1173310
• Device Catalogue Number: M1173310
• Device Lot Number: UNKNOWN
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/25/2024
• 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