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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 199 199
2023 314 314
2024 1600 1600
2025 48806 48809

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 14651 14651
Computer Software Problem 9542 9543
Activation Failure 4913 4913
Failure to Eject 4291 4291
Communication or Transmission Problem 3386 3387
Electrical /Electronic Property Problem 2485 2485
Application Program Problem 2275 2275
Loose or Intermittent Connection 1806 1806
Circuit Failure 1503 1503
Break 1478 1478
Application Network Problem 1185 1185
Application Program Freezes, Becomes Nonfunctional 1003 1003
Mechanical Jam 1001 1001
Labelling, Instructions for Use or Training Problem 872 872
No Apparent Adverse Event 633 633
Component Missing 540 540
Difficult to Open or Close 494 494
Installation-Related Problem 477 477
Failure to Power Up 456 456
Power Problem 446 446
Contamination 407 407
Date/Time-Related Software Problem 341 341
Data Problem 247 247
Computer Operating System Problem 235 236
Failure to Align 229 229
Leak/Splash 213 213
Key or Button Unresponsive/not Working 211 211
Appropriate Term/Code Not Available 208 208
Smoking 195 195
Ejection Problem 193 193
Display or Visual Feedback Problem 190 190
Unintended Application Program Shut Down 175 175
Unexpected Shutdown 167 167
Thermal Decomposition of Device 131 131
Connection Problem 124 124
Temperature Problem 115 115
Inadequate or Insufficient Training 107 107
Application Program Problem: Medication Error 100 100
Battery Problem 88 88
Complete Loss of Power 68 68
Device Emits Odor 66 66
Failure to Sense 58 58
Defective Component 57 57
Human-Device Interface Problem 55 55
Physical Resistance/Sticking 50 50
Device Displays Incorrect Message 49 49
Patient Data Problem 48 48
Display Difficult to Read 47 47
Misassembled 46 46
No Display/Image 46 46

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50798 50801
Insufficient Information 227 227
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
No Patient Involvement 10 10
Discomfort 9 9
Cardiac Arrest 8 8
Hemorrhage/Bleeding 8 8
Laceration(s) 6 6
Convulsion/Seizure 6 6
Pain 4 4
Atrial Fibrillation 3 3
Needle Stick/Puncture 3 3
Arrhythmia 2 2
Electric Shock 2 2
Low Blood Pressure/ Hypotension 2 2
Abrasion 2 2
Inadequate Pain Relief 2 2
Unspecified Kidney or Urinary Problem 2 2
Hypoglycemia 2 2
Cardiovascular Insufficiency 2 2
Anxiety 2 2
Skin Burning Sensation 1 1
Decreased Respiratory Rate 1 1
Respiratory Failure 1 1
Loss of consciousness 1 1
No Consequences Or Impact To Patient 1 1
Headache 1 1
Unspecified Respiratory Problem 1 1
Unspecified Heart Problem 1 1
Myocardial Infarction 1 1
Unspecified Tissue Injury 1 1
Eye Injury 1 1
Vomiting 1 1
Thrombosis/Thrombus 1 1
Pallor 1 1
Burn(s) 1 1
Cramp(s) /Muscle Spasm(s) 1 1
No Information 1 1
Respiratory Arrest 1 1
Nausea 1 1
Fetal Distress 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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