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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 536 536

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 512 512
Mechanical Problem 127 127
Unexpected Shutdown 68 68
Application Program Freezes, Becomes Nonfunctional 64 64
Failure to Eject 57 57
Smoking 46 46
Unintended Application Program Shut Down 28 28
Computer Operating System Problem 20 20
Communication or Transmission Problem 18 18
Defective Component 17 17
Application Program Problem 15 15
Temperature Problem 14 14
Appropriate Term/Code Not Available 10 10
Human-Device Interface Problem 9 9
Application Network Problem 9 9
Complete Loss of Power 8 8
Sparking 8 8
Electrical /Electronic Property Problem 7 7
Operating System Version or Upgrade Problem 7 7
No Display/Image 7 7
Fire 7 7
Failure to Power Up 6 6
Electrical Shorting 6 6
Battery Problem 5 5
Power Problem 5 5
Mechanical Jam 5 5
Break 5 5
Application Program Version or Upgrade Problem 5 5
Excessive Heating 4 4
Overheating of Device 4 4
Operating System Becomes Nonfunctional 4 4
Failure to Read Input Signal 4 4
Connection Problem 4 4
Wireless Communication Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Data Problem 3 3
Loss of Power 3 3
Improper or Incorrect Procedure or Method 3 3
Ejection Problem 3 3
Insufficient Information 3 3
Unintended System Motion 3 3
No Apparent Adverse Event 3 3
Inaccurate Delivery 2 2
Difficult to Open or Close 2 2
Intermittent Loss of Power 2 2
Use of Device Problem 2 2
Failure to Align 2 2
Key or Button Unresponsive/not Working 2 2
Material Split, Cut or Torn 2 2
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 862 862
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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