TPLC - Total Product Life Cycle

• Device: absorbent, carbon-dioxide
• Product Code: CBL
• Regulation Number: 868.5300
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	4	4
2020	10	10
2021	22	22
2022	20	20
2023	9	9
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	29	29
Crack	10	10
Mechanical Problem	5	5
Gas/Air Leak	3	3
Material Integrity Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Gas Output Problem	2	2
Break	2	2
Output Problem	2	2
Device Damaged Prior to Use	2	2
Decrease in Pressure	2	2
Physical Resistance/Sticking	1	1
No Pressure	1	1
Reset Problem	1	1
Mechanical Jam	1	1
Component or Accessory Incompatibility	1	1
Moisture or Humidity Problem	1	1
Volume Accuracy Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Alarm System	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Defective Device	1	1
Failure to Recalibrate	1	1
Loss of or Failure to Bond	1	1
Intermittent Communication Failure	1	1
Contamination	1	1
Data Problem	1	1
Defective Component	1	1
Material Discolored	1	1
Battery Problem	1	1
Product Quality Problem	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	47	47
Insufficient Information	7	7
No Consequences Or Impact To Patient	6	6
No Known Impact Or Consequence To Patient	3	3
Low Oxygen Saturation	2	2
No Patient Involvement	1	1
Hypoesthesia, Arm/Hand	1	1
Muscular Rigidity	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Armstrong Medical Services Limited	I	Sep-13-2021