TPLC - Total Product Life Cycle

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Device	bed, ac-powered adjustable hospital
Regulation Description	AC-powered adjustable hospital bed.
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	2017	2017
Unintended Movement	1178	1181
No Audible Alarm	895	1083
Electrical /Electronic Property Problem	482	2780
Detachment of Device or Device Component	444	444
Incorrect Measurement	424	2201
Mechanical Problem	373	1333
Defective Alarm	357	357
Unintended System Motion	255	725
Use of Device Problem	237	237
Sharp Edges	169	289
Device Fell	158	256
Activation Problem	151	151
Device Alarm System	136	136
Positioning Failure	132	211
Intermittent Loss of Power	128	774
Break	108	108
Adverse Event Without Identified Device or Use Problem	103	103
Appropriate Term/Code Not Available	94	94
Sparking	92	92
Material Frayed	77	77
Unclear Information	71	71
Insufficient Information	67	67
Device Slipped	53	53
Defective Component	46	46
No Apparent Adverse Event	43	45
Self-Activation or Keying	38	38
Circuit Failure	33	33
Fire	32	32
Loose or Intermittent Connection	32	32
Communication or Transmission Problem	31	31
Patient Device Interaction Problem	31	31
Collapse	30	30
Electrical Shorting	26	26
Smoking	23	22
Intermittent Continuity	21	21
Pressure Problem	20	20
Electromagnetic Interference	18	18
Material Twisted/Bent	18	18
Defective Device	17	17
Protective Measures Problem	15	15
Fracture	14	14
Entrapment of Device	14	14
Positioning Problem	14	14
Inflation Problem	13	13
Component Missing	13	13
Physical Resistance/Sticking	11	11
Arcing	10	10
False Alarm	10	10
Material Integrity Problem	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6635	11975
No Patient Involvement	846	2174
Insufficient Information	419	420
Fall	334	416
No Consequences Or Impact To Patient	165	255
Pressure Sores	154	154
Bone Fracture(s)	56	56
Laceration(s)	50	54
Pain	43	116
Physical Entrapment	29	29
Bruise/Contusion	28	32
Hip Fracture	28	28
Unspecified Tissue Injury	23	23
Head Injury	17	17
Abrasion	17	23
Electric Shock	16	16
Hematoma	14	14
Death	11	11
No Known Impact Or Consequence To Patient	10	10
Cardiac Arrest	10	10
Burn(s)	8	8
Hemorrhage/Bleeding	6	6
Skin Tears	6	6
Limb Fracture	6	6
Injury	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Shock	4	10
Bradycardia	4	4
Discomfort	4	4
Strangulation	4	4
Unintended Extubation	3	3
Decreased Respiratory Rate	3	3
Low Oxygen Saturation	3	3
Low Blood Pressure/ Hypotension	3	3
Loss of consciousness	3	3
Muscle/Tendon Damage	3	3
Erythema	3	3
Skin Discoloration	3	3
Unspecified Infection	3	3
Joint Dislocation	3	3
Brain Injury	3	3
Blister	3	3
Respiratory Arrest	3	3
Skull Fracture	3	3
Multiple Fractures	3	3
Syncope/Fainting	2	2
Full thickness (Third Degree) Burn	2	2
Respiratory Failure	2	2
Hypersensitivity/Allergic reaction	2	2
Partial thickness (Second Degree) Burn	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