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

Model Number M1173310

Device Problem No Pressure (2994)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

System could not pressurize.

Manufacturer Narrative

The system is not able to pressurize and would cause a delay in the patient's treatment of therapy.

Event Description

System could not pressurize.

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
• Type of Device: 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
• MDR Text Key: 339331932
• Report Number: 3010838917-2024-00201
• Device Sequence Number: 1
• Product Code: CBL
• UDI-Device Identifier: 10190752184329
• UDI-Public: 10190752184329
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/26/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other