TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Jam	1045	4567
Mechanical Problem	923	3178
Device Fell	486	856
Unintended Movement	432	536
Positioning Failure	392	1330
Difficult or Delayed Positioning	355	3236
Sharp Edges	301	1000
Fluid/Blood Leak	273	2523
Device Slipped	267	678
Device Tipped Over	231	369
Difficult to Remove	109	331
Protective Measures Problem	94	217
Device Dislodged or Dislocated	93	252
Electrical /Electronic Property Problem	93	541
Positioning Problem	81	165
Grounding Malfunction	80	260
Unstable	73	104
Adverse Event Without Identified Device or Use Problem	59	59
Patient Device Interaction Problem	57	65
Break	52	52
Insufficient Information	26	26
No Apparent Adverse Event	22	22
Detachment of Device or Device Component	22	23
Patient-Device Incompatibility	16	17
Use of Device Problem	14	14
Loose or Intermittent Connection	13	13
Collapse	12	12
Defective Component	10	10
Improper or Incorrect Procedure or Method	10	10
Physical Resistance/Sticking	10	10
Unintended System Motion	10	44
Intermittent Loss of Power	9	14
Fire	9	9
Fail-Safe Did Not Operate	8	31
Detachment Of Device Component	8	8
Unintended Collision	8	8
Material Integrity Problem	7	7
Component Missing	7	10
Therapeutic or Diagnostic Output Failure	6	6
Fail-Safe Problem	6	7
Mechanics Altered	6	6
Component Falling	6	6
Material Deformation	6	6
Device Operates Differently Than Expected	6	6
Corroded	5	5
Defective Device	5	5
No Audible Alarm	5	8
Battery Problem	5	5
Material Split, Cut or Torn	5	5
Material Twisted/Bent	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3215	13505
No Patient Involvement	1362	6093
Insufficient Information	293	433
Pain	168	647
No Consequences Or Impact To Patient	160	790
Injury	116	116
No Known Impact Or Consequence To Patient	81	215
Fall	65	326
Laceration(s)	60	76
Abrasion	45	109
Bruise/Contusion	44	246
Muscle/Tendon Damage	39	72
Bone Fracture(s)	36	36
Head Injury	20	22
Hematoma	14	18
Death	13	13
Unspecified Tissue Injury	12	12
Unspecified Musculoskeletal problem	10	107
Skin Tears	7	7
Hemorrhage/Bleeding	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
No Code Available	5	5
Sprain	5	14
No Information	5	5
Spinal Column Injury	5	5
Swelling/ Edema	4	7
Crushing Injury	4	4
Deformity/ Disfigurement	3	3
Headache	3	5
Tissue Damage	3	3
Limb Fracture	3	3
Physical Entrapment	3	3
Cardiac Arrest	3	3
Discomfort	3	12
Swelling	3	5
Neck Pain	3	3
Shock	2	2
Eye Injury	2	2
Concussion	2	2
Abdominal Pain	2	2
Damage to Ligament(s)	2	2
Uterine Perforation	2	2
Contusion	2	2
Patient Problem/Medical Problem	2	2
Hip Fracture	2	2
Inflammation	2	2
Tissue Breakdown	1	1
Ventilator Dependent	1	1
Internal Organ Perforation	1	1
Extubate	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ferno-Washington Inc	II	Nov-04-2022
2	Linet Spol. S.r.o.	II	Mar-04-2023
3	Stryker Medical Division of Stryker Corporation	II	Jul-12-2023
4	Stryker Medical Division of Stryker Corporation	II	Mar-15-2023
5	Stryker Medical Division of Stryker Corporation	II	Dec-14-2022
6	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021
7	Stryker Medical Division of Stryker Corporation	II	May-15-2019
8	Stryker Medical Division of Stryker Corporation	II	May-02-2018
9	Stryker Medical Division of Stryker Corporation	II	May-01-2018