TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Electrical /Electronic Property Problem	624	627
Detachment of Device or Device Component	525	525
Use of Device Problem	249	250
Insufficient Device Problem Information	161	161
Fracture	146	146
Break	135	135
Mechanical Problem	131	132
Device Tipped Over	105	105
Device Fell	103	103
Battery Problem	97	99
Unintended Movement	88	88
Material Split, Cut or Torn	84	84
Appropriate Device Problem Term/Code Not Available	64	64
Power Problem	48	48
Adverse Event Without Identified Device or Use Problem	43	43
Material Twisted/Bent	36	36
Failure to Charge	31	31
Mechanical Jam	30	31
Loose or Intermittent Connection	29	29
Charging Problem	28	28
Sparking	25	25
Unstable	23	23
Improper or Incorrect Procedure or Method	21	21
Key or Button Unresponsive/not Working	21	21
Material Deformation	20	20
Failure to Power Up	18	18
Naturally Worn	17	17
Unintended System Motion	17	17
No Apparent Adverse Event	16	16
Crack	14	14
Material Integrity Problem	14	14
Component Missing	14	14
Physical Resistance/Sticking	13	13
Material Rupture	12	12
Material Frayed	12	12
Overheating of Device	10	10
Complete Loss of Power	9	9
Premature Discharge of Battery	9	10
Compatibility Problem	9	9
Incomplete or Inadequate Connection	8	8
Activation Failure	8	8
Device Handling Problem	8	8
Intermittent Loss of Power	8	8
Misassembly by Users	7	7
Defective Component	7	7
Retraction Problem	6	6
Device Slipped	6	6
Fail-Safe Did Not Operate	6	7
Disconnection	6	6
Device Dislodged or Dislocated	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2017	2024
Fall	480	482
Bone Fracture(s)	180	180
Head Injury	153	153
Laceration(s)	131	131
Bruise/Contusion	130	130
Insufficient Information	81	81
Pain	66	66
Hematoma	57	57
Hip Fracture	37	37
Hemorrhage/Blood Loss/Bleeding	24	24
Multiple Fractures	24	24
Limb Fracture	23	23
Abrasion	22	22
Skin Tears	18	18
Unspecified Tissue Injury	16	16
Vertebral Fracture	16	16
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	14	14
Muscle/Tendon Damage	12	12
Swelling/ Edema	12	12
Joint Dislocation	11	11
Intracranial Hemorrhage	11	11
Concussion	10	10
Physical Entrapment	7	7
Back pain	7	7
Erythema	5	5
Headache	5	5
Skull Fracture	5	5
Electric Shock	5	5
Damage to Ligament(s)	5	5
Discomfort	4	4
Brain Injury	4	4
Anxiety	4	4
Tooth Fracture	3	3
Cardiac Arrest	3	3
Crushing Injury	2	2
Eye Burn	2	2
Cramp(s) /Muscle Spasm(s)	2	2
No Consequences Or Impact To Patient	2	2
Skin Discoloration	2	2
Confusion/ Disorientation	2	2
Movement Disorder	2	2
Epistaxis	2	2
Convulsion/Seizure	2	2
Hemothorax	2	2
Tissue Breakdown	2	2
Neck Pain	2	2
Strangulation	2	2
No Patient Involvement	2	2
Gastrointestinal Hemorrhage	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	II	Apr-10-2026
2	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	I	May-21-2022
3	Arjohuntleigh Magog, Inc.	II	May-24-2023
4	Arjohuntleigh Magog, Inc.	II	Sep-16-2021
5	Arjohuntleigh Magog, Inc.	II	Feb-09-2021
6	Baxter Healthcare Corporation	I	Jul-09-2025
7	Baxter Healthcare Corporation	II	Mar-28-2022
8	Community Products, LLC	II	Jan-22-2026
9	ETAC A/S	II	Feb-05-2026
10	Getinge Dominican Republic SA	II	Sep-13-2021
11	Hill-Rom, Inc.	II	Mar-11-2022
12	Hill-Rom, Inc.	II	Feb-16-2022
13	Hill-Rom, Inc.	II	Sep-30-2021
14	Hill-Rom, Inc.	I	Jan-29-2021
15	Human Care Hc Sweden Ab	II	Apr-05-2024
16	Human Care USA, Inc.	II	Mar-31-2022
17	Med-Mizer, Inc.	II	Mar-02-2023