TPLC - Total Product Life Cycle

show TPLC since

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
ADVANCED BRAIN MONITORING
	SUBSTANTIALLY EQUIVALENT	1
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
DYMEDIX DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ECTOSENSE NV
	SUBSTANTIALLY EQUIVALENT	3
EMBLA SYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
ENSODATA
	SUBSTANTIALLY EQUIVALENT	1
HAPPY HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
HUXLEY MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
INOVISE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ITAMAR MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	8
LARGAN MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MYCARDIO, LLC DBA SLEEPIMAGE.
	SUBSTANTIALLY EQUIVALENT	2
NEUROVIRTUAL USA, INC.
	SUBSTANTIALLY EQUIVALENT	3
ONERA B.V.
	SUBSTANTIALLY EQUIVALENT	3
PRANAQ PTE. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
RESAPP HEALTH
	SUBSTANTIALLY EQUIVALENT	1
RESONEA, INC.
	SUBSTANTIALLY EQUIVALENT	1
RESPIRONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SALTER LABS
	SUBSTANTIALLY EQUIVALENT	1
SIBEL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SNAP DIAGNOSTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
WATERMARK MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
WESPER, INC.
	SUBSTANTIALLY EQUIVALENT	2
WITHINGS
	SUBSTANTIALLY EQUIVALENT	1
ZEPHYR SLEEP TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	4

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	12	12
Overheating of Device	11	11
No Apparent Adverse Event	8	8
Circuit Failure	6	6
Battery Problem	6	6
Excessive Heating	5	5
Insufficient Information	4	4
Electrical /Electronic Property Problem	3	3
Power Problem	3	3
Device Operates Differently Than Expected	3	3
Thermal Decomposition of Device	3	3
Contamination	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Degraded	2	2
Failure to Power Up	2	2
Inappropriate/Inadequate Shock/Stimulation	2	2
Smoking	2	2
Contamination /Decontamination Problem	1	1
Patient Device Interaction Problem	1	1
No Audible Alarm	1	1
No Pressure	1	1
Use of Device Problem	1	1
Flare or Flash	1	1
Defective Device	1	1
Defective Component	1	1
Lack of Effect	1	1
Calibration Error	1	1
Inadequacy of Device Shape and/or Size	1	1
Electrical Shorting	1	1
Tidal Volume Fluctuations	1	1
Unsealed Device Packaging	1	1
Appropriate Term/Code Not Available	1	1
Unintended Electrical Shock	1	1
Human-Device Interface Problem	1	1
Naturally Worn	1	1
Accessory Incompatible	1	1
Improper Chemical Reaction	1	1
Sparking	1	1
False Positive Result	1	1
Device Issue	1	1
Device Displays Incorrect Message	1	1
No Flow	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
Burn(s)	9	9
Burning Sensation	7	7
Blister	6	6
Pain	5	5
No Known Impact Or Consequence To Patient	4	4
Discomfort	4	4
Sleep Dysfunction	3	3
Skin Inflammation/ Irritation	3	3
Burn, Thermal	3	3
Erythema	3	3
Swelling/ Edema	3	3
Headache	3	3
Injury	2	2
No Patient Involvement	2	2
Insufficient Information	2	2
Partial thickness (Second Degree) Burn	2	2
Full thickness (Third Degree) Burn	2	2
Increased Sensitivity	2	2
Bruise/Contusion	2	2
Complaint, Ill-Defined	1	1
Apnea	1	1
Electric Shock	1	1
Skin Irritation	1	1
Shock from Patient Lead(s)	1	1
Malaise	1	1
Scarring	1	1
Rash	1	1
Numbness	1	1
Tachycardia	1	1
No Consequences Or Impact To Patient	1	1
Sore Throat	1	1
Skin Burning Sensation	1	1

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