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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
Regulation Description Anesthetic cabinet, table, or tray.
Product CodeBRY
Regulation Number 868.6100
Device Class 1

MDR Year MDR Reports MDR Events
2020 13 13
2021 57 57
2022 199 200
2023 314 314
2024 1600 1600
2025 56587 56590

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 16121 16121
Computer Software Problem 11385 11386
Failure to Eject 5278 5278
Activation Failure 5108 5108
Communication or Transmission Problem 3629 3630
Electrical /Electronic Property Problem 3205 3205
Loose or Intermittent Connection 3002 3002
Application Program Problem 2984 2984
Circuit Failure 2561 2561
Break 2180 2180
Labelling, Instructions for Use or Training Problem 1628 1628
Application Network Problem 1409 1409
Application Program Freezes, Becomes Nonfunctional 1303 1303
Mechanical Jam 1192 1192
No Apparent Adverse Event 818 818
Component Missing 808 808
Installation-Related Problem 792 792
Contamination 641 641
Difficult to Open or Close 496 496
Failure to Power Up 473 473
Power Problem 469 469
Date/Time-Related Software Problem 388 388
Failure to Align 380 380
Data Problem 320 320
Computer Operating System Problem 275 276
Appropriate Term/Code Not Available 246 246
Leak/Splash 239 239
Unintended Application Program Shut Down 236 236
Key or Button Unresponsive/not Working 215 215
Smoking 200 200
Ejection Problem 200 200
Display or Visual Feedback Problem 193 193
Thermal Decomposition of Device 183 183
Unexpected Shutdown 174 174
Application Program Problem: Medication Error 156 156
Connection Problem 151 151
Inadequate or Insufficient Training 140 140
Battery Problem 117 117
Temperature Problem 115 115
Misassembled 86 86
Complete Loss of Power 85 85
Device Emits Odor 67 67
Failure to Sense 58 58
Device Displays Incorrect Message 58 58
Defective Component 57 57
Patient Data Problem 56 56
Human-Device Interface Problem 55 55
Physical Resistance/Sticking 50 51
Display Difficult to Read 49 49
No Display/Image 48 48

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 58578 58581
Insufficient Information 227 228
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
No Patient Involvement 10 10
Cardiac Arrest 9 9
Discomfort 9 9
Hemorrhage/Bleeding 8 8
Convulsion/Seizure 6 6
Laceration(s) 6 6
Pain 5 5
Atrial Fibrillation 3 3
Needle Stick/Puncture 3 3
Low Blood Pressure/ Hypotension 2 2
Arrhythmia 2 2
Electric Shock 2 2
Inadequate Pain Relief 2 2
Abrasion 2 2
Cardiovascular Insufficiency 2 2
Unspecified Kidney or Urinary Problem 2 2
Hypoglycemia 2 2
Anxiety 2 2
Skin Burning Sensation 1 1
Decreased Respiratory Rate 1 1
Respiratory Failure 1 1
Loss of consciousness 1 1
Headache 1 1
No Consequences Or Impact To Patient 1 1
Myocardial Infarction 1 1
Unspecified Respiratory Problem 1 1
Unspecified Heart Problem 1 1
Unspecified Tissue Injury 1 1
Eye Injury 1 1
Vomiting 1 1
Burn(s) 1 1
Thrombosis/Thrombus 1 1
Pallor 1 1
Cramp(s) /Muscle Spasm(s) 1 1
No Information 1 1
Fetal Distress 1 1
Respiratory Arrest 1 1
Nausea 1 1
Emotional Changes 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. II Oct-27-2025
2 CareFusion 303, Inc. II Aug-28-2025
3 CareFusion 303, Inc. III Aug-13-2025
4 CareFusion 303, Inc. II Jun-24-2025
5 CareFusion 303, Inc. II Apr-18-2025
6 CareFusion 303, Inc. II Apr-11-2025
7 CareFusion 303, Inc. II Apr-09-2025
8 CareFusion 303, Inc. II Apr-09-2025
9 CareFusion 303, Inc. II Mar-17-2025
10 CareFusion 303, Inc. II Feb-21-2025
11 CareFusion 303, Inc. II Feb-21-2025
12 CareFusion 303, Inc. II Feb-21-2025
13 CareFusion 303, Inc. II Feb-11-2025
14 CareFusion 303, Inc. II Feb-07-2025
15 CareFusion 303, Inc. II Feb-07-2025
16 CareFusion 303, Inc. II Jan-30-2025
17 CareFusion 303, Inc. II Jan-17-2025
18 CareFusion 303, Inc. II Jan-14-2025
19 CareFusion 303, Inc. II Dec-11-2024
20 CareFusion 303, Inc. II Aug-30-2024
21 CareFusion 303, Inc. II Aug-20-2024
22 CareFusion 303, Inc. II Aug-02-2024
23 CareFusion 303, Inc. II Jul-17-2024
24 CareFusion 303, Inc. II Jul-02-2024
25 CareFusion 303, Inc. II May-30-2024
26 CareFusion 303, Inc. II Oct-10-2023
27 CareFusion 303, Inc. II Sep-28-2023
28 CareFusion 303, Inc. II Jul-05-2023
29 CareFusion 303, Inc. II May-11-2023
30 CareFusion 303, Inc. II Mar-17-2023
31 CareFusion 303, Inc. II Jan-10-2023
32 CareFusion 303, Inc. II Sep-23-2022
33 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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