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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION BIRD SENTRY2; MIXER, BREATHING GASES, ANESTHESIA INHALATION
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CAREFUSION CORPORATION BIRD SENTRY2; MIXER, BREATHING GASES, ANESTHESIA INHALATION Back to Search Results
Model Number 30623-001
Device Problems Crack (1135); Protective Measures Problem (3015)
Patient Problem Insufficient Information (4580)
Event Date 10/15/2020
Event Type  malfunction  
Event 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).
 
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Brand Name
BIRD SENTRY2
Type of Device
MIXER, BREATHING GASES, ANESTHESIA INHALATION
Manufacturer (Section D)
CAREFUSION CORPORATION
26125 n. riverwoods blvd
mettawa IL 60045
MDR Report Key10733109
MDR Text Key213004670
Report Number10733109
Device Sequence Number1
Product Code BZR
UDI-Device Identifier10846446065053
UDI-Public(01)10846446065053
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number30623-001
Device Catalogue Number30623-001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/15/2020
Device Age18 MO
Event Location Hospital
Date Report to Manufacturer10/26/2020
Type of Device Usage Unknown
Patient Sequence Number1
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