TPLC - Total Product Life Cycle

show TPLC since

Device	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
CARDICARE COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN MARS MEDICAL PRODUCTS CO., 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	2
SHENZHEN CORERAY 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
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU LONGWAN MEDICAL DEVICE FACTORY
	SUBSTANTIALLY EQUIVALENT	1
WENZHOU RENHUA INSTRUMENTS CO., LTD
	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
Material Separation	14	14
Adverse Event Without Identified Device or Use Problem	8	8
Unraveled Material	7	7
Peeled/Delaminated	4	4
Pressure Problem	4	4
Material Deformation	4	4
Material Integrity Problem	3	3
Material Split, Cut or Torn	3	3
Break	3	3
Burst Container or Vessel	2	2
Material Fragmentation	2	2
Material Frayed	2	2
Material Puncture/Hole	2	2
Unable to Obtain Readings	2	2
Patient-Device Incompatibility	2	2
Contamination /Decontamination Problem	2	2
Material Protrusion/Extrusion	2	2
Material Twisted/Bent	1	1
Insufficient Information	1	1
Explosion	1	1
Air/Gas in Device	1	1
Problem with Sterilization	1	1
Stretched	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
Difficult to Advance	1	1
Gas/Air Leak	1	1
Device Contaminated During Manufacture or Shipping	1	1
Improper or Incorrect Procedure or Method	1	1
Low Readings	1	1
Dent in Material	1	1
Defective Device	1	1
Difficult to Remove	1	1
Delivered as Unsterile Product	1	1
Material Discolored	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	22	22
No Known Impact Or Consequence To Patient	12	12
Insufficient Information	10	10
No Consequences Or Impact To Patient	9	9
No Code Available	7	7
No Patient Involvement	6	6
Foreign Body In Patient	5	5
No Information	3	3
Death	2	2
Pain	2	2
Rash	2	2
Sepsis	2	2
Skin Discoloration	1	1
Loss of Range of Motion	1	1
Eye Injury	1	1
Anaphylactic Shock	1	1
Cerebrospinal Fluid Leakage	1	1
Superficial (First Degree) Burn	1	1
Not Applicable	1	1
Myalgia	1	1
Skin Inflammation	1	1
Post Operative Wound Infection	1	1
Needle Stick/Puncture	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1