TPLC - Total Product Life Cycle

show TPLC since

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
PARKER HANNIFIN CORPORATION
	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
Failure to Calibrate	4	4
No Apparent Adverse Event	4	4
Calibration Problem	4	4
Material Integrity Problem	4	4
No Flow	4	4
Improper Device Output	4	4
Medical Gas Supply Problem	3	3
Protective Measures Problem	3	3
False Alarm	3	3
Gas/Air Leak	3	3
Loose or Intermittent Connection	3	3
Appropriate Term/Code Not Available	2	2
Excess Flow or Over-Infusion	2	2
Delayed Alarm	2	2
Improper Flow or Infusion	2	2
Positioning Problem	2	2
Insufficient Information	2	2
Pressure Problem	2	2
Contamination	2	2
Output above Specifications	2	2
High Readings	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Failure to Deliver	2	2
Device Slipped	1	1
Material Frayed	1	1
Disconnection	1	1
Crack	1	1
Device Displays Incorrect Message	1	1
Kinked	1	1
Improper or Incorrect Procedure or Method	1	1
Display or Visual Feedback Problem	1	1
Naturally Worn	1	1
Melted	1	1
Device Handling Problem	1	1
No Audible Prompt/Feedback	1	1
Use of Incorrect Control/Treatment Settings	1	1
Material Twisted/Bent	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
Complaint, Ill-Defined	1	1
High Oxygen Saturation	1	1
Death	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