TPLC - Total Product Life Cycle

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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
Pressure Problem	4	4
Peeled/Delaminated	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Material Deformation	4	4
Material Split, Cut or Torn	3	3
Break	3	3
Material Integrity Problem	3	3
Material Frayed	2	2
Burst Container or Vessel	2	2
Material Puncture/Hole	2	2
Patient-Device Incompatibility	2	2
Contamination /Decontamination Problem	2	2
Material Fragmentation	2	2
Unable to Obtain Readings	2	2
Material Protrusion/Extrusion	2	2
Biocompatibility	2	2
Device Contaminated During Manufacture or Shipping	1	1
Difficult to Advance	1	1
Insufficient Information	1	1
Defective Device	1	1
Difficult to Remove	1	1
Air/Gas in Device	1	1
Stretched	1	1
Material Discolored	1	1
Dent in Material	1	1
Gas/Air Leak	1	1
Material Twisted/Bent	1	1
Problem with Sterilization	1	1
Delivered as Unsterile Product	1	1
Low Readings	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
Explosion	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	25	25
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
Sepsis	2	2
Rash	2	2
Pain	2	2
Contact Dermatitis	2	2
Caustic/Chemical Burns	2	2
Superficial (First Degree) Burn	1	1
Skin Infection	1	1
Not Applicable	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
Skin Inflammation	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	GE Medical Systems Information Technologies Inc	II	Jun-06-2024
2	ICU Medical, Inc.	II	May-01-2020
3	Suntech Medical, Inc.	II	Aug-14-2019
4	Volcano Corp	II	Jun-16-2022