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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
2021 57 57
2022 199 200
2023 314 314
2024 1600 1600
2025 61845 61848
2026 16367 16371

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 19709 19710
Computer Software Problem 11387 11388
Application Program Problem 6452 6453
Loose or Intermittent Connection 6263 6263
Circuit Failure 5666 5667
Activation Failure 5616 5616
Electrical /Electronic Property Problem 5421 5421
Failure to Eject 5300 5300
Break 4311 4311
Communication or Transmission Problem 3875 3876
Labelling, Instructions for Use or Training Problem 3247 3248
Application Network Problem 2274 2274
Application Program Freezes, Becomes Nonfunctional 1988 1988
Mechanical Jam 1920 1920
Installation-Related Problem 1726 1726
Component Missing 1517 1517
No Apparent Adverse Event 1509 1509
Contamination 1444 1444
Failure to Align 772 772
Power Problem 536 536
Data Problem 520 520
Failure to Power Up 510 510
Difficult to Open or Close 499 499
Appropriate Term/Code Not Available 431 431
Date/Time-Related Software Problem 395 395
Thermal Decomposition of Device 390 390
Unintended Application Program Shut Down 389 389
Computer Operating System Problem 276 277
Leak/Splash 263 263
Battery Problem 261 261
Key or Button Unresponsive/not Working 228 228
Ejection Problem 201 201
Smoking 201 201
Display or Visual Feedback Problem 194 194
Misassembled 179 179
Unexpected Shutdown 173 173
Application Program Version or Upgrade Problem 162 162
Application Program Problem: Medication Error 158 158
Connection Problem 151 151
Inadequate or Insufficient Training 140 140
Complete Loss of Power 134 134
Temperature Problem 117 117
Loss of or Failure to Bond 107 107
Device Displays Incorrect Message 91 91
Use of Device Problem 90 90
Device Emits Odor 67 67
Failure to Sense 58 58
Patient Data Problem 57 57
Physical Resistance/Sticking 57 58
Human-Device Interface Problem 55 55

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 80189 80196
Insufficient Information 231 232
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Cardiac Arrest 9 9
Discomfort 9 9
Hemorrhage/Bleeding 8 8
Convulsion/Seizure 6 6
Laceration(s) 6 6
Pain 5 5
Inadequate Pain Relief 3 3
Hypoglycemia 3 3
Atrial Fibrillation 3 3
Needle Stick/Puncture 3 3
Low Blood Pressure/ Hypotension 2 2
Cardiovascular Insufficiency 2 2
Anxiety 2 2
Unspecified Kidney or Urinary Problem 2 2
Abrasion 2 2
Electric Shock 2 2
Arrhythmia 2 2
Thrombosis/Thrombus 1 1
Pallor 1 1
Burn(s) 1 1
Chest Pain 1 1
Vomiting 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Respiratory Arrest 1 1
Nausea 1 1
Eye Injury 1 1
Fetal Distress 1 1
Tachycardia 1 1
Unspecified Tissue Injury 1 1
Emotional Changes 1 1
Hypersensitivity/Allergic reaction 1 1
Myocardial Infarction 1 1
Unspecified Heart Problem 1 1
Unspecified Respiratory Problem 1 1
Headache 1 1
Loss of consciousness 1 1
High Blood Pressure/ Hypertension 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. II Jan-08-2026
2 CareFusion 303, Inc. II Dec-19-2025
3 CareFusion 303, Inc. II Oct-27-2025
4 CareFusion 303, Inc. II Aug-28-2025
5 CareFusion 303, Inc. III Aug-13-2025
6 CareFusion 303, Inc. II Jun-24-2025
7 CareFusion 303, Inc. II Apr-18-2025
8 CareFusion 303, Inc. II Apr-11-2025
9 CareFusion 303, Inc. II Apr-09-2025
10 CareFusion 303, Inc. II Apr-09-2025
11 CareFusion 303, Inc. II Mar-17-2025
12 CareFusion 303, Inc. II Feb-21-2025
13 CareFusion 303, Inc. II Feb-21-2025
14 CareFusion 303, Inc. II Feb-21-2025
15 CareFusion 303, Inc. II Feb-11-2025
16 CareFusion 303, Inc. II Feb-07-2025
17 CareFusion 303, Inc. II Feb-07-2025
18 CareFusion 303, Inc. II Jan-30-2025
19 CareFusion 303, Inc. II Jan-17-2025
20 CareFusion 303, Inc. II Jan-14-2025
21 CareFusion 303, Inc. II Dec-11-2024
22 CareFusion 303, Inc. II Aug-30-2024
23 CareFusion 303, Inc. II Aug-20-2024
24 CareFusion 303, Inc. II Aug-02-2024
25 CareFusion 303, Inc. II Jul-17-2024
26 CareFusion 303, Inc. II Jul-02-2024
27 CareFusion 303, Inc. II May-30-2024
28 CareFusion 303, Inc. II Oct-10-2023
29 CareFusion 303, Inc. II Sep-28-2023
30 CareFusion 303, Inc. II Jul-05-2023
31 CareFusion 303, Inc. II May-11-2023
32 CareFusion 303, Inc. II Mar-17-2023
33 CareFusion 303, Inc. II Jan-10-2023
34 CareFusion 303, Inc. II Sep-23-2022
35 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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