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
ELECTROMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
MED SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	27	27
Insufficient Information	8	8
Increase in Pressure	5	5
Contamination	5	5
Use of Device Problem	4	4
Overheating of Device	4	4
Smoking	4	4
Material Split, Cut or Torn	3	3
Appropriate Term/Code Not Available	2	2
Sparking	2	2
Device Emits Odor	2	2
Intermittent Loss of Power	1	1
Noise, Audible	1	1
Pressure Problem	1	1
Crack	1	1
Patient-Device Incompatibility	1	1
Vibration	1	1
Electromagnetic Interference	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15	15
Bone Fracture(s)	7	7
Pneumothorax	6	6
No Patient Involvement	3	3
Vertebral Fracture	3	3
Patient Problem/Medical Problem	2	2
Insufficient Information	2	2
Abdominal Pain	1	1
Stroke/CVA	1	1
Hypersensitivity/Allergic reaction	1	1
Hemoptysis	1	1
Multiple Fractures	1	1
Itching Sensation	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Easy Bruising	1	1
Unspecified Ear or Labyrinth Problem	1	1
Burn(s)	1	1
Rash	1	1
Neck Pain	1	1
Hernia	1	1
Pain	1	1
Unspecified Kidney or Urinary Problem	1	1
Cough	1	1
Intervertebral Disc Compression or Protrusion	1	1
No Consequences Or Impact To Patient	1	1
Deformity/ Disfigurement	1	1
Respiratory Insufficiency	1	1
Aspiration Pneumonitis	1	1

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