MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. MEDISORB; ABSORBENT, CARBON-DIOXIDE

Catalog Number M11173310

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2018

Event Type  malfunction  

Event Description

When setting up for an operating room case, anesthesia found a crack in the plastic housing underneath the orange protective cover of a new co2 multi-absorber.The device was not use on the patient.Per manufacturer response to the hospital.(b)(4) has sold this division to vyaire.

• Brand Name: MEDISORB
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 n. riverwoods blvd; mettawa IL 60045
• MDR Report Key: 7305736
• MDR Text Key: 101264442
• Report Number: 7305736
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/18/2019
• Device Catalogue Number: M11173310
• Device Lot Number: 171104-0101
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1