TPLC - Total Product Life Cycle

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Device	ventilatory effort recorder
Regulation Description	Breathing frequency monitor.
Product Code	MNR
Regulation Number	868.2375
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACURABLE LIMITED
	SUBSTANTIALLY EQUIVALENT	3
BELUN TECHNOLOGY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BRESOTEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
CADWELL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
COMPUMEDICS LIMITED
	SUBSTANTIALLY EQUIVALENT	2
DORMOTECH MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ECTOSENSE NV
	SUBSTANTIALLY EQUIVALENT	2
1. K213463 NightOwl
2. K220028 NightOwl
ENSODATA
	SUBSTANTIALLY EQUIVALENT	1
HAPPY HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
HUXLEY MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
ITAMAR MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	4
LARGAN MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ONERA B.V.
	SUBSTANTIALLY EQUIVALENT	3
PRANAQ PTE. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
RESAPP HEALTH
	SUBSTANTIALLY EQUIVALENT	1
SIBEL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SNAP DIAGNOSTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
WESPER, INC.
	SUBSTANTIALLY EQUIVALENT	2
WITHINGS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Split, Cut or Torn	16	16
Adverse Event Without Identified Device or Use Problem	10	10
No Apparent Adverse Event	8	8
Circuit Failure	6	6
Excessive Heating	5	5
Overheating of Device	5	5
Battery Problem	3	3
Power Problem	3	3
Insufficient Information	2	2
Smoking	2	2
Contamination	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Patient Device Interaction Problem	2	2
Degraded	2	2
Failure to Power Up	2	2
Thermal Decomposition of Device	2	2
Appropriate Term/Code Not Available	2	2
Electrical /Electronic Property Problem	2	2
Accessory Incompatible	1	1
Unintended Electrical Shock	1	1
Defective Component	1	1
Defective Device	1	1
Contamination /Decontamination Problem	1	1
Use of Device Problem	1	1
Flare or Flash	1	1
Lack of Effect	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Human-Device Interface Problem	1	1
Improper Chemical Reaction	1	1
False Positive Result	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	55	55
Superficial (First Degree) Burn	11	11
Blister	7	7
Discomfort	4	4
Pain	4	4
Swelling/ Edema	4	4
Skin Inflammation/ Irritation	3	3
Burning Sensation	3	3
Erythema	3	3
Partial thickness (Second Degree) Burn	3	3
Increased Sensitivity	2	2
Sleep Dysfunction	2	2
Bruise/Contusion	2	2
Insufficient Information	2	2
Burn(s)	1	1
Headache	1	1
Apnea	1	1
Tachycardia	1	1
Electric Shock	1	1
Malaise	1	1
Numbness	1	1
Skin Burning Sensation	1	1
Shock from Patient Lead(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	NOX MEDICAL	II	Oct-05-2021