TPLC - Total Product Life Cycle

• Device: percussor, powered-electric
• Regulation Description: Powered percussor.
• Product Code: BYI
• Regulation Number: 868.5665
• Device Class: 2

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
TACTILE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	15	15
2022	16	16
2023	9	10
2024	19	19
2025	39	39
2026	23	23

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	65	65
Material Split, Cut or Torn	25	26
Insufficient Information	10	10
Sparking	6	6
Contamination	5	5
Overheating of Device	5	5
Smoking	4	4
Appropriate Term/Code Not Available	4	4
Use of Device Problem	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
Grounding Malfunction	1	1
Electrical /Electronic Property Problem	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	42	43
Bone Fracture(s)	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Pneumothorax	6	6
Vertebral Fracture	3	3
Atrial Fibrillation	3	3
Cardiac Arrest	3	3
Insufficient Information	3	3
Abdominal Pain	2	2
Unspecified Infection	2	2
Low Oxygen Saturation	2	2
Deformity/ Disfigurement	2	2
Pain	2	2
Dyspnea	2	2
Aspiration Pneumonitis	1	1
Liver Laceration(s)	1	1
Granuloma	1	1
Bacterial Infection	1	1
Physical Asymmetry	1	1
Intervertebral Disc Compression or Protrusion	1	1
Unspecified Respiratory Problem	1	1
Cough	1	1
Pneumonia	1	1
Eye Injury	1	1
Unspecified Kidney or Urinary Problem	1	1
Laceration(s)	1	1
Twiddlers Syndrome	1	1
Respiratory Tract Infection	1	1
Hernia	1	1
Vomiting	1	1
Chest Pain	1	1
Neck Pain	1	1
Visual Disturbances	1	1
Skin Erosion	1	1
Rash	1	1
Burn(s)	1	1
Transient Ischemic Attack	1	1
Easy Bruising	1	1
Blister	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Itching Sensation	1	1
Multiple Fractures	1	1
Hemoptysis	1	1
Aspiration/Inhalation	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