MAUDE Adverse Event Report: VYAIRE MEDICAL OY MEDISORB; ABSORBER CARBON-DIOXIDE

Model Number M1173311

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2020

Event Type  malfunction  

Event Description

Product defect discovered during anesthesia pre-check.Fda safety report id# (b)(4).

• Brand Name: MEDISORB
• Type of Device: ABSORBER CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL OY; helsinki, fn ; FI
• MDR Report Key: 9829048
• MDR Text Key: 184156482
• Report Number: MW5093730
• Device Sequence Number: 1
• Product Code: BSF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1173311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1