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
ICU MEDICAL SALES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	68	68
Unraveled Material	44	44
Break	25	25
Difficult to Remove	16	16
Flaked	15	15
Material Fragmentation	13	13
Peeled/Delaminated	10	10
Material Frayed	9	9
Material Protrusion/Extrusion	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Material Deformation	6	6
Appropriate Term/Code Not Available	6	6
Stretched	5	5
Uncoiled	5	5
Contamination /Decontamination Problem	5	5
Fracture	4	4
Burst Container or Vessel	4	4
Insufficient Information	4	4
Material Split, Cut or Torn	4	4
Device Operates Differently Than Expected	4	4
Patient-Device Incompatibility	3	3
Material Twisted/Bent	3	3
Difficult to Advance	3	3
Device Contaminated During Manufacture or Shipping	3	3
Kinked	3	3
Wire	2	2
Guidewire	2	2
Detachment Of Device Component	2	2
Sticking	2	2
Device Contamination with Chemical or Other Material	2	2
Defective Device	2	2
Detachment of Device or Device Component	2	2
Degraded	2	2
Inflation Problem	2	2
Material Puncture/Hole	2	2
Retraction Problem	1	1
Use of Device Problem	1	1
Out-Of-Box Failure	1	1
Split	1	1
Hole In Material	1	1
Crack	1	1
Tube	1	1
Bent	1	1
Human Factors Issue	1	1
Deformation Due to Compressive Stress	1	1
Problem with Sterilization	1	1
Noise, Audible	1	1
Material Integrity Problem	1	1
Unintended Movement	1	1
Device Subassembly	1	1
Explosion	1	1
Unable to Obtain Readings	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Dent in Material	1	1
Cuff	1	1
Connector	1	1
Leak/Splash	1	1
Delivered as Unsterile Product	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	102	102
No Consequences Or Impact To Patient	49	49
No Code Available	35	35
Foreign Body In Patient	25	25
No Patient Involvement	21	21
Device Embedded In Tissue or Plaque	19	19
No Information	4	4
Blood Loss	3	3
Pain	3	3
Sepsis	3	3
Swelling	2	2
Skin Inflammation	2	2
Hematoma	2	2
Low Blood Pressure/ Hypotension	2	2
Death	2	2
Cardiac Perforation	2	2
Not Applicable	1	1
Fistula	1	1
Hemorrhage/Bleeding	1	1
Laceration(s)	1	1
Nerve Damage	1	1
Pneumonia	1	1
Anaphylactic Shock	1	1
Bacterial Infection	1	1
Occlusion	1	1
Perforation	1	1
Rash	1	1
Hypersensitivity/Allergic reaction	1	1
Cyst(s)	1	1
Dyspnea	1	1
Fatigue	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Thrombosis	1	1
Excessive Tear Production	1	1
Malaise	1	1