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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
2017 3 3
2018 5 5
2019 6 6
2020 13 13
2021 57 57
2022 176 176

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 82 82
Failure to Eject 19 19
Defective Component 18 18
Smoking 10 10
Communication or Transmission Problem 9 9
Computer Operating System Problem 9 9
Unexpected Shutdown 9 9
Appropriate Term/Code Not Available 7 7
Application Program Freezes, Becomes Nonfunctional 7 7
Complete Loss of Power 6 6
Sparking 6 6
Electrical /Electronic Property Problem 6 6
No Apparent Adverse Event 5 5
Mechanical Problem 4 4
Electrical Shorting 4 4
Application Program Problem 3 3
Application Program Version or Upgrade Problem 3 3
Connection Problem 3 3
No Display/Image 3 3
Operating System Version or Upgrade Problem 3 3
Power Problem 3 3
Excessive Heating 3 3
Improper or Incorrect Procedure or Method 3 3
Unintended Application Program Shut Down 3 3
Ejection Problem 2 2
Wireless Communication Problem 2 2
Insufficient Information 2 2
Data Problem 2 2
Fire 2 2
Failure to Power Up 2 2
Failure to Read Input Signal 2 2
Inaccurate Delivery 2 2
Application Network Problem 2 2
Battery Problem 2 2
Mechanical Jam 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Operating System Becomes Nonfunctional 2 2
Naturally Worn 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Microbial Contamination of Device 1 1
Detachment of Device or Device Component 1 1
Device Operational Issue 1 1
Failure to Align 1 1
Date/Time-Related Software Problem 1 1
Device Displays Incorrect Message 1 1
Use of Device Problem 1 1
Peeled/Delaminated 1 1
Display or Visual Feedback Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Application Program Problem: Medication Error 1 1
Problem with Software Installation 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Physical Resistance/Sticking 1 1
Program or Algorithm Execution Failure 1 1
Intermittent Communication Failure 1 1
Key or Button Unresponsive/not Working 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 110 110
No Clinical Signs, Symptoms or Conditions 103 103
No Patient Involvement 10 10
No Known Impact Or Consequence To Patient 10 10
Discomfort 4 4
Atrial Fibrillation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Kidney or Urinary Problem 2 2
Arrhythmia 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
No Information 1 1
Convulsion/Seizure 1 1
Unspecified Heart Problem 1 1
Unspecified Respiratory Problem 1 1
Cardiac Arrest 1 1
Death 1 1
Emotional Changes 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Optical Nerve Damage 1 1
Pain 1 1
Respiratory Distress 1 1
No Consequences Or Impact To Patient 1 1
Anxiety 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. II Sep-23-2022
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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