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	168	740
Pressure Problem	75	75
Deflation Problem	49	49
Measurement System Incompatibility	33	33
Inflation Problem	32	32
Delivered as Unsterile Product	24	24
Increase in Pressure	17	25
Material Split, Cut or Torn	15	15
Output Problem	11	11
Break	10	10
Device Alarm System	9	9
Material Puncture/Hole	9	9
Infusion or Flow Problem	9	9
Patient Device Interaction Problem	9	9
Material Frayed	8	8
Therapeutic or Diagnostic Output Failure	8	8
No Apparent Adverse Event	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Use of Device Problem	7	7
Product Quality Problem	6	6
Calibration Problem	6	6
Application Program Version or Upgrade Problem	5	5
Noise, Audible	4	4
Incorrect Measurement	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Self-Activation or Keying	3	3
Electromagnetic Interference	3	3
Appropriate Term/Code Not Available	3	3
Protective Measures Problem	3	3
Computer Software Problem	3	3
No Pressure	3	3
Material Integrity Problem	3	3
Unintended Deflation	3	3
Battery Problem	2	2
Radiofrequency Interference (RFI)	2	2
Intermittent Loss of Power	2	2
Thermal Decomposition of Device	2	2
Charging Problem	2	2
Difficult to Remove	2	2
Display or Visual Feedback Problem	2	2
Use of Incorrect Control/Treatment Settings	2	2
Defective Device	2	2
Material Deformation	2	2
Insufficient Information	2	2
Detachment of Device or Device Component	2	2
Failure to Shut Off	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	614	1150
No Consequences Or Impact To Patient	100	155
No Known Impact Or Consequence To Patient	69	76
No Patient Involvement	65	88
Insufficient Information	48	345
Blood Loss	5	5
Blister	5	5
Skin Discoloration	5	5
Hemorrhage/Bleeding	5	5
Bruise/Contusion	5	7
Numbness	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