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
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	30	30
Leak/Splash	7	7
No Audible Alarm	5	5
Gas Output Problem	4	4
Device Contamination with Body Fluid	4	4
Output Problem	4	4
Insufficient Information	3	3
Component Misassembled	3	3
No Flow	2	2
Fire	2	2
Appropriate Term/Code Not Available	2	2
Inaccurate Delivery	2	2
Therapeutic or Diagnostic Output Failure	2	2
Contamination	2	2
Gas/Air Leak	2	2
Misassembled	2	2
Noise, Audible	1	1
Fluid/Blood Leak	1	1
Improper or Incorrect Procedure or Method	1	1
Display or Visual Feedback Problem	1	1
Melted	1	1
Medical Gas Supply Problem	1	1
No Apparent Adverse Event	1	1
Device Handling Problem	1	1
No Audible Prompt/Feedback	1	1
Infusion or Flow Problem	1	1
Device Damaged by Another Device	1	1
Improper Flow or Infusion	1	2
Failure to Align	1	1
High Readings	1	1
Failure to Deliver	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Positioning Problem	1	1
Material Integrity Problem	1	1
Defective Device	1	1
Volume Accuracy Problem	1	1
No Display/Image	1	1
Break	1	1
Pressure Problem	1	1
Device-Device Incompatibility	1	1
Activation, Positioning or Separation Problem	1	1
Material Frayed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	78	79
Low Oxygen Saturation	12	12
Insufficient Information	8	8
Respiratory Arrest	1	1
Hypoxia	1	1