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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 24153 24153

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 11443 11443
Computer Software Problem 6397 6397
Communication or Transmission Problem 2369 2369
Failure to Eject 1659 1659
Electrical /Electronic Property Problem 1022 1022
Difficult to Open or Close 362 362
Power Problem 348 348
Mechanical Jam 325 325
Application Program Freezes, Becomes Nonfunctional 279 279
Failure to Power Up 193 193
Display or Visual Feedback Problem 159 159
Application Network Problem 144 144
Smoking 136 136
Application Program Problem 130 130
Date/Time-Related Software Problem 129 129
Unexpected Shutdown 127 127
Temperature Problem 106 106
Connection Problem 98 98
Key or Button Unresponsive/not Working 96 96
Computer Operating System Problem 79 79
Ejection Problem 78 78
Data Problem 66 66
Thermal Decomposition of Device 57 57
Appropriate Term/Code Not Available 55 55
Failure to Sense 54 54
Defective Component 53 53
Break 52 52
Inadequate or Insufficient Training 51 51
Human-Device Interface Problem 50 50
No Display/Image 42 42
Unintended Application Program Shut Down 35 35
Labelling, Instructions for Use or Training Problem 34 34
Device Emits Odor 31 31
Loss of Power 30 30
Complete Loss of Power 29 29
Patient Data Problem 26 26
Loose or Intermittent Connection 25 25
Wireless Communication Problem 25 25
Leak/Splash 24 24
Battery Problem 23 23
Application Program Problem: Medication Error 22 22
Sparking 22 22
Inadequate User Interface 22 22
Loss of Data 20 20
Electrical Power Problem 18 18
Use of Device Problem 18 18
Detachment of Device or Device Component 16 16
Installation-Related Problem 16 16
Intermittent Communication Failure 16 16
Overheating of Device 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26180 26180
Insufficient Information 224 224
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
No Patient Involvement 10 10
Cardiac Arrest 8 8
Discomfort 6 6
Convulsion/Seizure 6 6
Hemorrhage/Bleeding 6 6
Pain 4 4
Laceration(s) 4 4
Atrial Fibrillation 3 3
Needle Stick/Puncture 3 3
Arrhythmia 2 2
Unspecified Kidney or Urinary Problem 2 2
Hypoglycemia 2 2
Anxiety 2 2
Cardiovascular Insufficiency 2 2
High Blood Pressure/ Hypertension 1 1
Hypersensitivity/Allergic reaction 1 1
Emotional Changes 1 1
Nausea 1 1
Respiratory Arrest 1 1
Fetal Distress 1 1
No Information 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Pallor 1 1
Thrombosis/Thrombus 1 1
Eye Injury 1 1
Unspecified Heart Problem 1 1
Unspecified Respiratory Problem 1 1
Myocardial Infarction 1 1
No Consequences Or Impact To Patient 1 1
Inadequate Pain Relief 1 1
Headache 1 1
Respiratory Failure 1 1
Decreased Respiratory Rate 1 1
Low Blood Pressure/ Hypotension 1 1

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