MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. AIRLIFE¿; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 2K8012

Device Problem Moisture Damage (1405)

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

Event Date 08/06/2020

Event Type  malfunction  

Event Description

One of our therapists was setting up a ventilator and noticed that the bacterial/viral filter she was going to use was damp/wet and had some condensation in it.We opened another filter and also noticed that it was wet/damp.I called the manufacturer to file a product concern with them.The manufacturer is vyaire.We opened several other filters and noticed that not all of them were damp/wet.

• Brand Name: AIRLIFE¿
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 nw riverwoods blvd; mettawa IL 60045
• MDR Report Key: 10447619
• MDR Text Key: 204193196
• Report Number: 10447619
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/17/2020,08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2K8012
• Device Catalogue Number: 2K8012
• Device Lot Number: 0004144635
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1