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TPLC
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show TPLC since
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Device
cabinet, table and tray, anesthesia
Product Code
BRY
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
100
100
Device Problems
MDRs with this Device Problem
Events in those MDRs
Computer Software Problem
255
255
Mechanical Problem
60
60
Unexpected Shutdown
57
57
Application Program Freezes, Becomes Nonfunctional
42
42
Failure to Eject
41
41
Smoking
21
21
Computer Operating System Problem
20
20
Unintended Application Program Shut Down
19
19
Defective Component
17
17
Communication or Transmission Problem
15
15
Application Program Problem
14
14
Temperature Problem
10
10
Human-Device Interface Problem
9
9
Appropriate Term/Code Not Available
9
9
Complete Loss of Power
8
8
Sparking
8
8
No Display/Image
7
7
Fire
7
7
Operating System Version or Upgrade Problem
7
7
Electrical /Electronic Property Problem
6
6
Failure to Power Up
6
6
Application Network Problem
6
6
Break
5
5
Mechanical Jam
5
5
Electrical Shorting
5
5
Power Problem
4
4
Operating System Becomes Nonfunctional
4
4
Failure to Read Input Signal
4
4
Application Program Version or Upgrade Problem
4
4
Battery Problem
4
4
Connection Problem
4
4
Loss of Power
3
3
Improper or Incorrect Procedure or Method
3
3
Unintended System Motion
3
3
Overheating of Device
3
3
Excessive Heating
3
3
Insufficient Information
3
3
Wireless Communication Problem
3
3
Ejection Problem
3
3
No Apparent Adverse Event
2
2
Data Problem
2
2
Intermittent Loss of Power
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Use of Device Problem
2
2
Inaccurate Delivery
2
2
Key or Button Unresponsive/not Working
2
2
Failure to Align
1
1
Date/Time-Related Software Problem
1
1
Microbial Contamination of Device
1
1
Loss of Data
1
1
Detachment of Device or Device Component
1
1
Electrical Power Problem
1
1
Peeled/Delaminated
1
1
Failure to Run on Battery
1
1
Material Frayed
1
1
Image Display Error/Artifact
1
1
Leak/Splash
1
1
Display or Visual Feedback Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Therapeutic or Diagnostic Output Failure
1
1
Problem with Software Installation
1
1
Protective Measures Problem
1
1
Computer System Security Problem
1
1
Naturally Worn
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Program or Algorithm Execution Failure
1
1
Intermittent Communication Failure
1
1
Application Program Problem: Medication Error
1
1
Physical Resistance/Sticking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
436
436
Insufficient Information
205
205
No Patient Involvement
10
10
No Known Impact Or Consequence To Patient
4
4
Discomfort
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Convulsion/Seizure
3
3
Pain
3
3
Atrial Fibrillation
3
3
Anxiety
2
2
Unspecified Kidney or Urinary Problem
2
2
Thrombosis/Thrombus
1
1
Unspecified Heart Problem
1
1
Unspecified Respiratory Problem
1
1
Arrhythmia
1
1
No Consequences Or Impact To Patient
1
1
Inadequate Pain Relief
1
1
Extubate
1
1
No Information
1
1
Cardiac Arrest
1
1
Death
1
1
Emotional Changes
1
1
Headache
1
1
Hypersensitivity/Allergic reaction
1
1
High Blood Pressure/ Hypertension
1
1
Laceration(s)
1
1
Nausea
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
CareFusion 303, Inc.
II
Oct-10-2023
2
CareFusion 303, Inc.
II
Sep-28-2023
3
CareFusion 303, Inc.
II
Jul-05-2023
4
CareFusion 303, Inc.
II
May-11-2023
5
CareFusion 303, Inc.
II
Mar-17-2023
6
CareFusion 303, Inc.
II
Jan-10-2023
7
CareFusion 303, Inc.
II
Sep-23-2022
8
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
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