TPLC - Total Product Life Cycle

• Device: chamber, hyperbaric
• Regulation Description: Hyperbaric chamber.
• Product Code: CBF
• Regulation Number: 868.5470
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
OXAVITA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
OXYHEAL MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2016	5	5
2017	9	9
2018	5	5
2019	3	3
2020	4	4
2021	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Operates Differently Than Expected	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Device Displays Incorrect Message	2	2
Fail-Safe Problem	2	2
Burst Container or Vessel	2	2
Decrease in Pressure	2	2
Break	2	2
Mechanical Problem	2	2
Noise, Audible	2	2
Improper Flow or Infusion	1	1
Output Problem	1	1
Device Alarm System	1	1
Mechanics Altered	1	1
Pressure Problem	1	1
Detachment Of Device Component	1	1
Complete Blockage	1	1
Material Separation	1	1
Device Reprocessing Problem	1	1
Fire	1	1
Patient-Device Incompatibility	1	1
Improper Device Output	1	1
Fail-Safe Did Not Operate	1	1
Gas Output Problem	1	1
No Apparent Adverse Event	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	8	8
No Known Impact Or Consequence To Patient	4	4
No Clinical Signs, Symptoms or Conditions	4	4
Death	4	4
No Information	3	3
Convulsion/Seizure	2	2
Muscle Spasm(s)	1	1
No Code Available	1	1
No Patient Involvement	1	1
Myocardial Infarction	1	1
Patient Problem/Medical Problem	1	1
Low Oxygen Saturation	1	1
Cardiopulmonary Arrest	1	1
Fever	1	1
Hepatitis	1	1
Pain	1	1