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
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	34	34
Leak/Splash	8	8
No Audible Alarm	5	5
Output Problem	4	4
Gas Output Problem	3	3
Fire	3	3
Device Contamination with Body Fluid	3	3
Device Alarm System	3	3
Component Misassembled	3	3
Insufficient Information	3	3
Therapeutic or Diagnostic Output Failure	3	3
No Flow	2	2
Appropriate Term/Code Not Available	2	2
Protective Measures Problem	2	2
Inaccurate Delivery	2	2
Misassembled	2	2
Gas/Air Leak	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Contamination	2	2
Defective Device	2	2
Output above Specifications	1	1
Positioning Problem	1	1
Failure to Deliver	1	1
High Readings	1	1
Failure to Align	1	1
Material Integrity Problem	1	1
Improper Flow or Infusion	1	1
Device Damaged by Another Device	1	1
Infusion or Flow Problem	1	1
No Audible Prompt/Feedback	1	1
Device Handling Problem	1	1
No Apparent Adverse Event	1	1
Crack	1	1
Volume Accuracy Problem	1	1
Medical Gas Supply Problem	1	1
No Display/Image	1	1
Pressure Problem	1	1
Melted	1	1
Display or Visual Feedback Problem	1	1
Activation, Positioning or Separation Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Material Frayed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	79	79
Low Oxygen Saturation	14	14
Insufficient Information	9	9
No Information	3	3
No Patient Involvement	2	2
No Consequences Or Impact To Patient	2	2
Superficial (First Degree) Burn	1	1
Respiratory Arrest	1	1
Hypoxia	1	1