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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
2019 6 6
2020 13 13
2021 57 57
2022 196 196
2023 314 314
2024 590 590

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 542 542
Mechanical Problem 131 131
Unexpected Shutdown 69 69
Application Program Freezes, Becomes Nonfunctional 65 65
Failure to Eject 58 58
Smoking 55 55
Unintended Application Program Shut Down 29 29
Communication or Transmission Problem 20 20
Computer Operating System Problem 20 20
Defective Component 17 17
Temperature Problem 16 16
Application Program Problem 15 15
Human-Device Interface Problem 10 10
Appropriate Term/Code Not Available 10 10
Application Network Problem 9 9
Sparking 8 8
Electrical /Electronic Property Problem 8 8
Complete Loss of Power 8 8
No Display/Image 7 7
Fire 7 7
Operating System Version or Upgrade Problem 7 7
Failure to Power Up 6 6
Electrical Shorting 6 6
Mechanical Jam 5 5
Break 5 5
Application Program Version or Upgrade Problem 5 5
Power Problem 5 5
Battery Problem 5 5
Failure to Read Input Signal 4 4
Operating System Becomes Nonfunctional 4 4
Overheating of Device 4 4
Wireless Communication Problem 4 4
Connection Problem 4 4
Excessive Heating 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Loss of Power 3 3
Unintended System Motion 3 3
No Apparent Adverse Event 3 3
Data Problem 3 3
Ejection Problem 3 3
Insufficient Information 3 3
Failure to Align 2 2
Use of Device Problem 2 2
Inaccurate Delivery 2 2
Key or Button Unresponsive/not Working 2 2
Difficult to Open or Close 2 2
Material Split, Cut or Torn 2 2
Intermittent Loss of Power 2 2
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 916 916
Insufficient Information 214 214
No Patient Involvement 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Known Impact Or Consequence To Patient 4 4
Discomfort 4 4
Atrial Fibrillation 3 3
Cardiac Arrest 3 3
Laceration(s) 3 3
Pain 3 3
Convulsion/Seizure 3 3
Unspecified Kidney or Urinary Problem 2 2
Anxiety 2 2
High Blood Pressure/ Hypertension 1 1
Arrhythmia 1 1
Death 1 1
Hypersensitivity/Allergic reaction 1 1
Emotional Changes 1 1
Nausea 1 1
Respiratory Arrest 1 1
No Information 1 1
Thrombosis/Thrombus 1 1
Myocardial Infarction 1 1
Unspecified Heart Problem 1 1
Unspecified Respiratory Problem 1 1
Headache 1 1
No Consequences Or Impact To Patient 1 1
Inadequate Pain Relief 1 1
Extubate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CareFusion 303, Inc. II Aug-30-2024
2 CareFusion 303, Inc. II Aug-20-2024
3 CareFusion 303, Inc. II Aug-02-2024
4 CareFusion 303, Inc. II Jul-17-2024
5 CareFusion 303, Inc. II Jul-02-2024
6 CareFusion 303, Inc. II May-30-2024
7 CareFusion 303, Inc. II Oct-10-2023
8 CareFusion 303, Inc. II Sep-28-2023
9 CareFusion 303, Inc. II Jul-05-2023
10 CareFusion 303, Inc. II May-11-2023
11 CareFusion 303, Inc. II Mar-17-2023
12 CareFusion 303, Inc. II Jan-10-2023
13 CareFusion 303, Inc. II Sep-23-2022
14 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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