MAUDE Adverse Event Report: CAREFUSION CORPORATION BIRD SENTRY2; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	30623-001
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Carefusion bird sentry 2 high flow air/oxygen blenders have been experiencing large case cracking in both the front and back assemblies.These devices are only 12-18 months old.The cracks are affecting the operation of the device.The buttons are not able to be reached or lose function, and it presents an infection control risk for fluid ingress and bacteria growth.Manufacturer response for high flow air/oxygen blender, bird sentry 2 (per site reporter).There is no warranty coverage for these devices.Payment required for repair work ((b)(6) per device).

• Brand Name: BIRD SENTRY2
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFUSION CORPORATION; 26125 n. riverwoods blvd; mettawa IL 60045
• MDR Report Key: 10733109
• Report Number: 10733109
• Device Sequence Number: 16422582
• Product Code: BZR
• UDI-Device Identifier: 10846446065053
• UDI-Public: (01)10846446065053
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2020
• Report Date (Section F): 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 30623-001
• Device Catalogue Number: 30623-001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/15/2020