TPLC - Total Product Life Cycle

show TPLC since

Device	bed, ac-powered adjustable hospital
Product Code	FNL
Regulation Number	880.5100
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Split, Cut or Torn	1642	1642
Unintended Movement	1082	1101
No Audible Alarm	1020	1227
Electrical /Electronic Property Problem	531	2999
Incorrect Measurement	504	3245
Detachment of Device or Device Component	466	466
Mechanical Problem	438	1693
Defective Alarm	365	365
Device Alarm System	358	358
Unintended System Motion	316	912
Use of Device Problem	252	252
Sharp Edges	181	314
Device Fell	171	278
Device Slipped	149	149
Intermittent Loss of Power	142	919
Activation Problem	132	132
Positioning Failure	127	202
Adverse Event Without Identified Device or Use Problem	116	116
Break	116	116
Appropriate Term/Code Not Available	98	98
Sparking	89	89
Unclear Information	71	71
Material Frayed	70	70
Insufficient Information	69	69
Defective Component	57	57
Self-Activation or Keying	47	47
No Apparent Adverse Event	43	45
Loose or Intermittent Connection	39	39
Fire	38	38
Circuit Failure	33	33
Communication or Transmission Problem	32	32
Positioning Problem	31	39
Collapse	28	28
Patient Device Interaction Problem	27	27
Smoking	26	25
Electrical Shorting	25	25
Pressure Problem	20	20
Intermittent Continuity	20	20
Defective Device	20	20
Electromagnetic Interference	18	18
Material Twisted/Bent	16	16
Inflation Problem	14	14
Component Missing	14	14
Entrapment of Device	14	14
Protective Measures Problem	14	14
Physical Resistance/Sticking	14	14
Fracture	13	13
Arcing	11	11
Improper or Incorrect Procedure or Method	11	11
False Alarm	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5892	10989
No Patient Involvement	1691	5017
Insufficient Information	411	411
Fall	355	440
No Consequences Or Impact To Patient	265	363
Pressure Sores	147	147
No Known Impact Or Consequence To Patient	91	91
Laceration(s)	64	68
Bone Fracture(s)	63	63
Pain	45	118
Bruise/Contusion	32	36
Hip Fracture	31	31
Physical Entrapment	30	30
Death	30	30
Unspecified Tissue Injury	23	23
Head Injury	21	21
Abrasion	18	24
Electric Shock	17	17
Hematoma	15	15
Injury	14	14
Cardiac Arrest	8	8
Burn(s)	8	8
Hemorrhage/Bleeding	7	7
Skin Tears	6	6
Limb Fracture	6	6
Shock	5	28
Hemorrhage, Subdural	5	5
Skull Fracture	4	4
Joint Dislocation	4	4
Discomfort	4	4
Loss of consciousness	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Bradycardia	4	4
Low Blood Pressure/ Hypotension	3	3
Respiratory Arrest	3	3
Low Oxygen Saturation	3	3
Unintended Extubation	3	3
Brain Injury	3	3
Decreased Respiratory Rate	3	3
No Code Available	3	3
Multiple Fractures	3	3
Erythema	3	3
Blister	3	3
Unspecified Infection	3	3
Skin Discoloration	3	3
Muscle/Tendon Damage	3	3
Asphyxia	2	2
Swelling/ Edema	2	2
Strangulation	2	2
Swelling	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	II	Dec-22-2023
2	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	II	Sep-29-2021
3	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	II	Aug-18-2020
4	Baxter Healthcare Corporation	II	Oct-25-2024
5	Baxter Healthcare Corporation	II	Jun-26-2023
6	Baxter Healthcare Corporation	II	Nov-14-2022
7	Baxter Healthcare Corporation	I	Oct-31-2022
8	Hill-Rom, Inc.	II	Jul-30-2020
9	Hill-Rom, Inc.	II	Jun-03-2020
10	Linet Spol. S.r.o.	II	Jan-04-2021
11	Oakworks Inc	II	Jun-06-2022
12	Stryker Medical Division of Stryker Corporation	II	Dec-01-2023
13	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021
14	Umano Medical, Inc.	II	May-26-2022
15	Umano Medical, Inc.	II	Jun-02-2020