TPLC - Total Product Life Cycle

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Device	blood pressure cuff
Regulation Description	Blood pressure cuff.
Definition	A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Product Code	DXQ
Regulation Number	870.1120
Device Class	2

Premarket Reviews
Manufacturer	Decision
AVITA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CARDICARE COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
HONSUN(NANTONG)CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
JKH USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
LITTLE DOCTOR ELECTRONIC (NANTONG)CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI CAREMATE MEDICAL DEVICE CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN CORERAY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MEDKE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN PLINMA TECHNOLOGY CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SINO-K MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU MINHUA MEDICAL APPARATUS SUPPLIES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
UNIMED MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU LONGWAN MEDICAL DEVICE FACTORY
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU XIKANG MEDICAL INSTRUMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU XIKANG MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUXI EXANOVO MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG LUDE TECHNOLOGY DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	8	8
Pressure Problem	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Unraveled Material	4	4
Peeled/Delaminated	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Material Separation	3	3
Patient-Device Incompatibility	2	3
Material Integrity Problem	2	2
Unable to Obtain Readings	2	2
Biocompatibility	2	2
Material Frayed	1	1
Unexpected Shutdown	1	1
Break	1	1
Electrical Power Problem	1	1
Insufficient Information	1	1
Defective Device	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Air/Gas in Device	1	1
Battery Problem	1	1
Material Discolored	1	1
Gas/Air Leak	1	1
Material Deformation	1	1
Low Readings	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	44	44
Insufficient Information	10	10
No Known Impact Or Consequence To Patient	2	2
Rash	2	3
Pain	2	2
Contact Dermatitis	2	2
Caustic/Chemical Burns	2	2
No Consequences Or Impact To Patient	2	2
Superficial (First Degree) Burn	1	1
Skin Infection	1	1
Skin Inflammation/ Irritation	1	1
Myalgia	1	1
Skin Discoloration	1	1
Post Operative Wound Infection	1	1
Needle Stick/Puncture	1	1
Loss of Range of Motion	1	1
Viral Infection	1	1
Eye Injury	1	1
Muscle/Tendon Damage	1	1
Anaphylactic Shock	1	1
Tachycardia	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Cerebrospinal Fluid Leakage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Apr-15-2025
2	GE Medical Systems Information Technologies Inc	II	Jun-06-2024
3	ICU Medical, Inc.	II	May-01-2020
4	Volcano Corp	II	Jun-16-2022