TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
MCEWEN AND ASSOCIATES CONSULTING LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	256	256
Gas/Air Leak	221	221
Decrease in Pressure	165	717
Pressure Problem	70	70
Deflation Problem	49	49
Inflation Problem	32	32
Measurement System Incompatibility	27	27
Delivered as Unsterile Product	24	24
Increase in Pressure	15	20
Material Split, Cut or Torn	15	15
Output Problem	11	11
Infusion or Flow Problem	9	9
Material Puncture/Hole	9	9
Device Alarm System	9	9
Break	9	9
Patient Device Interaction Problem	9	9
Therapeutic or Diagnostic Output Failure	8	8
No Apparent Adverse Event	7	7
Material Frayed	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Use of Device Problem	7	7
Product Quality Problem	6	6
Calibration Problem	5	5
Manufacturing, Packaging or Shipping Problem	4	4
Noise, Audible	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Incorrect Measurement	4	4
Electromagnetic Interference	3	3
Computer Software Problem	3	3
Self-Activation or Keying	3	3
No Pressure	3	3
Protective Measures Problem	3	3
Appropriate Term/Code Not Available	3	3
Material Integrity Problem	3	3
Unintended Deflation	3	3
Material Deformation	2	2
Difficult to Remove	2	2
Battery Problem	2	2
Charging Problem	2	2
Radiofrequency Interference (RFI)	2	2
Defective Device	2	2
Insufficient Information	2	2
Intermittent Loss of Power	2	2
Use of Incorrect Control/Treatment Settings	2	2
Thermal Decomposition of Device	2	2
Display or Visual Feedback Problem	2	2
Electrical /Electronic Property Problem	1	1
Excess Flow or Over-Infusion	1	0
Low Audible Alarm	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	602	1119
No Consequences Or Impact To Patient	100	155
No Known Impact Or Consequence To Patient	69	76
No Patient Involvement	65	88
Insufficient Information	47	326
Blood Loss	5	5
Blister	5	5
Skin Discoloration	5	5
Hemorrhage/Bleeding	5	5
Numbness	4	4
Bruise/Contusion	4	4
No Code Available	3	3
Pain	3	3
Swelling/ Edema	3	3
Hematoma	2	2
Burn(s)	2	2
Erythema	2	2
Missing Value Reason	2	2
Cyanosis	1	1
Unspecified Infection	1	1
Patient Problem/Medical Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Tingling	1	1
Exsanguination	1	1
Irritation	1	1
Rash	1	1
Foreign Body In Patient	1	1
Ecchymosis	1	1
Laceration(s)	1	1
Discharge	1	1
Convulsion/Seizure	1	1
Tissue Breakdown	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Delfi Medical Innovations, Inc.	II	May-06-2020
2	Stryker Corporation	II	Apr-04-2023
3	Stryker Instruments Div. of Stryker Corporation	II	Dec-02-2019
4	Stryker Sustainability Solutions	II	Jul-17-2024
5	Stryker Sustainability Solutions	II	Apr-01-2023
6	Stryker Sustainability Solutions	II	Feb-22-2022
7	Stryker Sustainability Solutions	II	Apr-27-2020
8	Zimmer Surgical Inc	II	Jan-28-2020