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	259	259
Decrease in Pressure	189	748
Gas/Air Leak	156	156
Pressure Problem	67	67
Deflation Problem	42	42
Measurement System Incompatibility	37	37
Delivered as Unsterile Product	31	31
Inflation Problem	28	28
Increase in Pressure	17	27
Material Split, Cut or Torn	12	12
Output Problem	11	11
Patient Device Interaction Problem	11	11
Packaging Problem	11	11
Device Alarm System	10	10
Infusion or Flow Problem	9	9
Material Puncture/Hole	8	8
Use of Device Problem	8	8
No Apparent Adverse Event	7	7
Therapeutic or Diagnostic Output Failure	7	7
Break	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Product Quality Problem	6	6
Calibration Problem	6	6
Material Frayed	5	5
Application Program Version or Upgrade Problem	5	5
Noise, Audible	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Incorrect Measurement	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Self-Activation or Keying	3	3
Electromagnetic Interference	3	3
Protective Measures Problem	3	3
Unintended Deflation	3	3
Computer Software Problem	3	3
Radiofrequency Interference (RFI)	2	2
Intermittent Loss of Power	2	2
Display or Visual Feedback Problem	2	2
Appropriate Term/Code Not Available	2	2
Detachment of Device or Device Component	2	2
Material Deformation	2	2
Charging Problem	2	2
Thermal Decomposition of Device	2	2
No Pressure	2	2
Battery Problem	2	2
Difficult to Remove	2	2
Defective Device	2	2
Insufficient Information	2	2
Patient-Device Incompatibility	2	2
Material Twisted/Bent	1	1
Excess Flow or Over-Infusion	1	0

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	687	1249
Insufficient Information	54	375
No Consequences Or Impact To Patient	50	70
No Patient Involvement	30	30
No Known Impact Or Consequence To Patient	23	23
Blister	6	6
Bruise/Contusion	6	8
Skin Discoloration	5	5
Hemorrhage/Bleeding	5	5
Blood Loss	4	4
Numbness	4	4
Pain	4	4
Swelling/ Edema	4	4
No Code Available	2	2
Hematoma	2	2
Erythema	2	2
Cyanosis	1	1
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Tingling	1	1
Exsanguination	1	1
Burn(s)	1	1
Irritation	1	1
Rash	1	1
Ecchymosis	1	1
Laceration(s)	1	1
Muscle/Tendon Damage	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 Sustainability Solutions	II	Jul-17-2024
4	Stryker Sustainability Solutions	II	Apr-01-2023
5	Stryker Sustainability Solutions	II	Feb-22-2022
6	Stryker Sustainability Solutions	II	Apr-27-2020
7	Zimmer Surgical Inc	II	Jan-28-2020