TPLC - Total Product Life Cycle

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Device	mixer, breathing gases, anesthesia inhalation
Regulation Description	Breathing gas mixer.
Product Code	BZR
Regulation Number	868.5330
Device Class	2

Premarket Reviews
Manufacturer	Decision
BALDUS SEDATION GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
DEHAS MEDICAL SYSTEMS GMBH
	SUBSTANTIALLY EQUIVALENT	1
1. K221494 Quality Mix Blender, Oxymixer
FISHER & PAYKEL HEALTHCARE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
MAXTEC, LLC
	SUBSTANTIALLY EQUIVALENT	1
PARKER HANNIFIN
	SUBSTANTIALLY EQUIVALENT	1
PARKER HANNIFIN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	33	33
Leak/Splash	8	8
No Audible Alarm	5	5
Gas Output Problem	5	5
Device Contamination with Body Fluid	4	4
Insufficient Device Problem Information	3	3
Component Misassembled	3	3
Device Alarm System	2	2
Contamination	2	2
Fire	2	2
Gas/Air Leak	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Misassembled	2	2
Volume Accuracy Problem	1	1
Improper or Incorrect Procedure or Method	1	1
No Audible Prompt/Feedback	1	1
Inaccurate Delivery	1	1
High Readings	1	1
Failure to Align	1	1
No Display/Image	1	1
Display or Visual Feedback Problem	1	1
Material Frayed	1	1
Device Damaged by Another Device	1	1
Improper Flow or Infusion	1	2
Infusion or Flow Problem	1	1
Medical Gas Supply Problem	1	1
No Flow	1	1
Pressure Problem	1	1
No Apparent Adverse Event	1	1
Device Handling Problem	1	1
Output above Specifications	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	81	82
Low Oxygen Saturation	15	15
Insufficient Information	10	10
No Information	3	3
No Patient Involvement	2	2
No Consequences Or Impact To Patient	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Respiratory Arrest	1	1
Hypoxia	1	1
Superficial (First Degree) Burn	1	1