TPLC - Total Product Life Cycle

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Device	mixer, breathing gases, anesthesia inhalation
Product Code	BZR
Regulation Number	868.5330
Device Class	2

Premarket Reviews
Manufacturer	Decision
ATOM MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BALDUS SEDATION GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
CARDINAL HEALTH 207, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEHAS MEDICAL SYSTEMS GMBH
	SUBSTANTIALLY EQUIVALENT	1
GENTEC (SHANGHAI) CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LINDE HEALTHCARE AB
	SUBSTANTIALLY EQUIVALENT	1
MAXTEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MAXTEC, LLC
	SUBSTANTIALLY EQUIVALENT	2
O-TWO MEDICAL TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
O-TWO MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PARKER HANNIFIN
	SUBSTANTIALLY EQUIVALENT	1
PRECISION MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	39	39
Inaccurate Delivery	32	32
Device Operates Differently Than Expected	29	29
No Audible Alarm	21	21
Leak/Splash	17	17
Device Alarm System	17	17
Output Problem	8	8
Infusion or Flow Problem	7	7
Out-Of-Box Failure	6	6
Fire	5	5
Therapeutic or Diagnostic Output Failure	5	5
Defective Device	5	5
Gas Output Problem	5	5
Improper Device Output	4	4
Calibration Problem	4	4
Material Integrity Problem	4	4
No Flow	4	4
No Apparent Adverse Event	4	4
Failure to Calibrate	4	4
False Alarm	3	3
Loose or Intermittent Connection	3	3
Gas/Air Leak	3	3
Protective Measures Problem	3	3
Medical Gas Supply Problem	3	3
Pressure Problem	2	2
Output above Specifications	2	2
Failure to Deliver	2	2
Contamination	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
High Readings	2	2
Appropriate Term/Code Not Available	2	2
Improper Flow or Infusion	2	2
Excess Flow or Over-Infusion	2	2
Delayed Alarm	2	2
Positioning Problem	2	2
Insufficient Information	2	2
Incorrect Or Inadequate Test Results	1	1
Failure to Align	1	1
Material Twisted/Bent	1	1
Use of Incorrect Control/Treatment Settings	1	1
Device Slipped	1	1
No Audible Prompt/Feedback	1	1
Device Handling Problem	1	1
Misconnection	1	1
Disconnection	1	1
Material Frayed	1	1
No Device Output	1	1
Device Displays Incorrect Message	1	1
Display or Visual Feedback Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	99	99
No Clinical Signs, Symptoms or Conditions	67	67
Low Oxygen Saturation	25	25
No Known Impact Or Consequence To Patient	20	20
No Consequences Or Impact To Patient	11	11
Insufficient Information	8	8
No Information	7	7
Superficial (First Degree) Burn	2	2
Respiratory Distress	2	2
Death	1	1
Complaint, Ill-Defined	1	1
High Oxygen Saturation	1	1
No Code Available	1	1
Respiratory Arrest	1	1
Abnormal Blood Gases	1	1
Abdominal Distention	1	1
Overdose	1	1
Retinal Injury	1	1
Hypoxia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CAREstream Medical LLC	II	Aug-22-2018
2	O-Two Medical Technologies, Inc.	II	Aug-22-2018