TPLC - Total Product Life Cycle

• Device: cabinet, table and tray, anesthesia
• Product Code: BRY
• Regulation Number: 868.6100
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	5	5
2019	6	6
2020	13	13
2021	57	57
2022	196	196
2023	140	140

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	138	138
Failure to Eject	34	34
Unexpected Shutdown	31	31
Computer Operating System Problem	19	19
Defective Component	18	18
Smoking	17	17
Application Program Freezes, Becomes Nonfunctional	17	17
Application Program Problem	13	13
Communication or Transmission Problem	11	11
Mechanical Problem	11	11
Appropriate Term/Code Not Available	9	9
Complete Loss of Power	8	8
Temperature Problem	7	7
Operating System Version or Upgrade Problem	7	7
Sparking	7	7
Electrical /Electronic Property Problem	6	6
Unintended Application Program Shut Down	6	6
Fire	5	5
Break	5	5
Failure to Power Up	4	4
Failure to Read Input Signal	4	4
No Display/Image	4	4
Electrical Shorting	4	4
Human-Device Interface Problem	4	4
Mechanical Jam	4	4
No Apparent Adverse Event	4	4
Insufficient Information	3	3
Ejection Problem	3	3
Excessive Heating	3	3
Improper or Incorrect Procedure or Method	3	3
Application Program Version or Upgrade Problem	3	3
Battery Problem	3	3
Connection Problem	3	3
Application Network Problem	2	2
Inaccurate Delivery	2	2
Use of Device Problem	2	2
Loss of Power	2	2
Unintended System Motion	2	2
Wireless Communication Problem	2	2
Key or Button Unresponsive/not Working	2	2
Data Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Operating System Becomes Nonfunctional	2	2
Power Problem	2	2
Problem with Software Installation	1	1
Protective Measures Problem	1	1
Naturally Worn	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Application Program Problem: Medication Error	1	1
Program or Algorithm Execution Failure	1	1
Intermittent Communication Failure	1	1
Patient Device Interaction Problem	1	1
Physical Resistance/Sticking	1	1
Intermittent Loss of Power	1	1
Overheating of Device	1	1
Peeled/Delaminated	1	1
Failure to Run on Battery	1	1
Display or Visual Feedback Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Image Display Error/Artifact	1	1
Leak/Splash	1	1
Microbial Contamination of Device	1	1
Failure to Align	1	1
Date/Time-Related Software Problem	1	1
Loss of Data	1	1
Detachment of Device or Device Component	1	1
Device Operational Issue	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	192	192
No Clinical Signs, Symptoms or Conditions	182	182
No Patient Involvement	10	10
No Known Impact Or Consequence To Patient	7	7
Discomfort	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Atrial Fibrillation	3	3
Anxiety	2	2
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
Thrombosis/Thrombus	1	1
Unspecified Heart Problem	1	1
Unspecified Respiratory Problem	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
Optical Nerve Damage	1	1
Pain	1	1
Respiratory Distress	1	1
No Consequences Or Impact To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CareFusion 303, Inc.	II	Jul-05-2023
2	CareFusion 303, Inc.	II	May-11-2023
3	CareFusion 303, Inc.	II	Mar-17-2023
4	CareFusion 303, Inc.	II	Jan-10-2023
5	CareFusion 303, Inc.	II	Sep-23-2022
6	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022