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

Model Number REF: M1173310

Device Problems Crack (1135); Unintended Ejection (1234); Pressure Problem (3012)

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

Event Date 01/29/2016

Event Type  malfunction  

Event Description

Hard plastic soda lime absorb canisters are easily cracked during handling causing high pressure leaks in the anesthesia ventilator system.The cracks are usually small and hard to locate by visual inspection.When compared to the old soda lime absorbers used at our facility - these current co2 absorbers are more susceptible to breaks and cracks.

• 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: 7859513
• MDR Text Key: 119662215
• Report Number: 7859513
• Device Sequence Number: 1
• Product Code: BSF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: REF: M1173310
• Device Catalogue Number: REF: M1173310
• Device Lot Number: 180404-0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1