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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. BD Pyxis¿ MedStation¿ 4000; Cabinet, Table And Tray, Anesthesia

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CAREFUSION 303, INC. BD Pyxis¿ MedStation¿ 4000; Cabinet, Table And Tray, Anesthesia Back to Search Results
Model Number 500001002002
Medical Device Problem Codes Mechanical Problem (1384); Activation Failure (3270)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/07/2026
Type of Reportable Event Malfunction
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Brand Name
BD Pyxis¿ MedStation¿ 4000
Common Device Name
Cabinet, Table And Tray, Anesthesia
Manufacturer (Section D)
CAREFUSION 303, INC.
3750 torrey view ct
san diego CA 92130
Manufacturer (Section G)
CareFusion 303, INC.
10020 pacific mesa blvd
san diego CA 92121 -438
Manufacturer Contact
brett wilko
3750 torrey view ct
san diego, CA 92130
+1(858)617-2000
MDR Report Key50587834
Report Number2016493-2026-60138
Device Sequence Number13122153
Product Code BRY
UDI-Device Identifier10885403512650
UDI-Public(01)10885403512650
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Health Professional,User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 09/21/2026
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 Other
Device Model Number500001002002
Device Catalogue Number314
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Supplement Date Received by Manufacturer09/03/2026
Initial Report FDA Received Date09/03/2026
Supplement Report FDA Received Date09/24/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured08/01/2012
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Patient Sequence Number1
Patient SexUnknown
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