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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cabinet, table and tray, anesthesia
Product CodeBRY
Regulation Number 868.6100
Device Class 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 13 13
2021 57 57
2022 196 196
2023 314 314
2024 915 915

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 646 646
Mechanical Problem 199 199
Smoking 77 77
Unexpected Shutdown 73 73
Failure to Eject 72 72
Application Program Freezes, Becomes Nonfunctional 68 68
Date/Time-Related Software Problem 41 41
Temperature Problem 37 37
Unintended Application Program Shut Down 29 29
Communication or Transmission Problem 22 22
Computer Operating System Problem 20 20
Electrical /Electronic Property Problem 18 18
Defective Component 17 17
Application Program Problem 15 15
Sparking 11 11
Appropriate Term/Code Not Available 11 11
Application Network Problem 10 10
Human-Device Interface Problem 10 10
Complete Loss of Power 8 8
Electrical Shorting 7 7
Power Problem 7 7
Failure to Power Up 7 7
Operating System Version or Upgrade Problem 7 7
Fire 7 7
No Display/Image 7 7
Battery Problem 6 6
Mechanical Jam 6 6
Thermal Decomposition of Device 6 6
Application Program Version or Upgrade Problem 5 5
Break 5 5
No Apparent Adverse Event 5 5
Wireless Communication Problem 4 4
Insufficient Information 4 4
Connection Problem 4 4
Overheating of Device 4 4
Excessive Heating 4 4
Improper or Incorrect Procedure or Method 4 4
Operating System Becomes Nonfunctional 4 4
Flare or Flash 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Failure to Read Input Signal 4 4
Unintended System Motion 3 3
Loss of Power 3 3
Labelling, Instructions for Use or Training Problem 3 3
Intermittent Loss of Power 3 3
Data Problem 3 3
Failure to Align 3 3
Use of Device Problem 3 3
Ejection Problem 3 3
Material Split, Cut or Torn 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1240 1240
Insufficient Information 215 215
No Patient Involvement 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Known Impact Or Consequence To Patient 4 4
Discomfort 4 4
Atrial Fibrillation 3 3
Cardiac Arrest 3 3
Pain 3 3
Laceration(s) 3 3
Convulsion/Seizure 3 3
Unspecified Kidney or Urinary Problem 2 2
Anxiety 2 2
High Blood Pressure/ Hypertension 1 1
Death 1 1
Hypersensitivity/Allergic reaction 1 1
Arrhythmia 1 1
Emotional Changes 1 1
Nausea 1 1
Respiratory Arrest 1 1
No Information 1 1
Thrombosis/Thrombus 1 1
Unspecified Heart Problem 1 1
Unspecified Respiratory Problem 1 1
Myocardial Infarction 1 1
Extubate 1 1
No Consequences Or Impact To Patient 1 1
Inadequate Pain Relief 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. II Dec-11-2024
2 CareFusion 303, Inc. II Aug-30-2024
3 CareFusion 303, Inc. II Aug-20-2024
4 CareFusion 303, Inc. II Aug-02-2024
5 CareFusion 303, Inc. II Jul-17-2024
6 CareFusion 303, Inc. II Jul-02-2024
7 CareFusion 303, Inc. II May-30-2024
8 CareFusion 303, Inc. II Oct-10-2023
9 CareFusion 303, Inc. II Sep-28-2023
10 CareFusion 303, Inc. II Jul-05-2023
11 CareFusion 303, Inc. II May-11-2023
12 CareFusion 303, Inc. II Mar-17-2023
13 CareFusion 303, Inc. II Jan-10-2023
14 CareFusion 303, Inc. II Sep-23-2022
15 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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