TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
AIRPHYSIO PTY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORPORTATION
	SUBSTANTIALLY EQUIVALENT	1
CHONGQING MOFFY INNOVATION TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ELECTROMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXEMPLAR MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
MED SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SYNCHRONY MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	58	58
Material Split, Cut or Torn	22	23
Insufficient Information	9	9
Sparking	6	6
Contamination	5	5
Overheating of Device	5	5
Smoking	4	4
Use of Device Problem	3	3
Appropriate Term/Code Not Available	3	3
Device Emits Odor	2	2
Material Frayed	1	1
Unexpected Shutdown	1	1
No Display/Image	1	1
Crack	1	1
Vibration	1	1
Increase in Pressure	1	1
Intermittent Loss of Power	1	1
Temperature Problem	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	39	40
Bone Fracture(s)	9	9
Pneumothorax	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Vertebral Fracture	3	3
Atrial Fibrillation	3	3
Abdominal Pain	2	2
Unspecified Infection	2	2
Deformity/ Disfigurement	2	2
Cardiac Arrest	2	2
Pain	2	2
Insufficient Information	2	2
Liver Laceration(s)	1	1
Aspiration Pneumonitis	1	1
Low Oxygen Saturation	1	1
Granuloma	1	1
Bacterial Infection	1	1
Physical Asymmetry	1	1
Intervertebral Disc Compression or Protrusion	1	1
Cough	1	1
Eye Injury	1	1
Pneumonia	1	1
Laceration(s)	1	1
Dyspnea	1	1
Unspecified Kidney or Urinary Problem	1	1
Respiratory Tract Infection	1	1
Twiddlers Syndrome	1	1
Chest Pain	1	1
Hernia	1	1
Skin Erosion	1	1
Visual Disturbances	1	1
Rash	1	1
Burn(s)	1	1
Neck Pain	1	1
Transient Ischemic Attack	1	1
Blister	1	1
Itching Sensation	1	1
Easy Bruising	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Multiple Fractures	1	1
Hemoptysis	1	1
Unspecified Gastrointestinal Problem	1	1
Vitreous Detachment	1	1
Hypersensitivity/Allergic reaction	1	1
Stroke/CVA	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smiths Medical ASD Inc.	II	Apr-29-2021