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
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	9	9
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
Degraded	2	2
Failure to Power Up	2	2
Thermal Decomposition of Device	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
Patient Device Interaction 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
Appropriate Term/Code Not Available	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	54	54
Superficial (First Degree) Burn	11	11
Blister	6	6
Discomfort	4	4
Pain	4	4
Skin Inflammation/ Irritation	3	3
Burning Sensation	3	3
Swelling/ Edema	3	3
Sleep Dysfunction	2	2
Insufficient Information	2	2
Erythema	2	2
Increased Sensitivity	2	2
Bruise/Contusion	2	2
Apnea	1	1
Electric Shock	1	1
Shock from Patient Lead(s)	1	1
Malaise	1	1
Burn(s)	1	1
Numbness	1	1
Tachycardia	1	1
Partial thickness (Second Degree) Burn	1	1
Headache	1	1
Skin Burning Sensation	1	1

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