TPLC - Total Product Life Cycle

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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	1377	1377
No Audible Alarm	1000	1202
Unintended Movement	984	1003
Electrical /Electronic Property Problem	511	2888
Incorrect Measurement	489	3187
Detachment of Device or Device Component	445	445
Mechanical Problem	431	1671
Defective Alarm	363	363
Device Alarm System	356	356
Unintended System Motion	309	896
Use of Device Problem	243	243
Sharp Edges	176	302
Device Fell	163	263
Device Slipped	149	149
Intermittent Loss of Power	134	870
Positioning Failure	119	183
Activation Problem	118	118
Break	113	113
Adverse Event Without Identified Device or Use Problem	107	107
Appropriate Term/Code Not Available	94	94
Sparking	81	81
Unclear Information	71	71
Material Frayed	68	68
Insufficient Information	66	66
Defective Component	56	56
Self-Activation or Keying	47	47
No Apparent Adverse Event	40	42
Loose or Intermittent Connection	39	39
Fire	36	36
Circuit Failure	31	31
Positioning Problem	31	39
Communication or Transmission Problem	30	30
Patient Device Interaction Problem	28	28
Collapse	27	27
Smoking	25	24
Electrical Shorting	24	24
Pressure Problem	20	20
Defective Device	20	20
Intermittent Continuity	20	20
Electromagnetic Interference	18	18
Material Twisted/Bent	16	16
Entrapment of Device	14	14
Physical Resistance/Sticking	14	14
Component Missing	14	14
Protective Measures Problem	14	14
Inflation Problem	13	13
Improper or Incorrect Procedure or Method	11	11
Fracture	11	11
Material Integrity Problem	10	10
Failure to Sense	10	20

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5281	10149
No Patient Involvement	1691	5017
Insufficient Information	390	390
Fall	335	417
No Consequences Or Impact To Patient	265	363
Pressure Sores	143	143
No Known Impact Or Consequence To Patient	91	91
Laceration(s)	62	63
Bone Fracture(s)	60	60
Pain	42	115
Bruise/Contusion	32	36
Death	30	30
Hip Fracture	29	29
Physical Entrapment	25	25
Unspecified Tissue Injury	23	23
Head Injury	19	19
Abrasion	17	23
Electric Shock	16	16
Injury	14	14
Hematoma	12	12
Burn(s)	8	8
Hemorrhage/Bleeding	7	7
Cardiac Arrest	6	6
Skin Tears	6	6
Shock	5	28
Limb Fracture	5	5
Hemorrhage, Subdural	5	5
Skull Fracture	4	4
Bradycardia	4	4
Joint Dislocation	4	4
Loss of consciousness	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Muscle/Tendon Damage	3	3
No Code Available	3	3
Brain Injury	3	3
Low Blood Pressure/ Hypotension	3	3
Low Oxygen Saturation	3	3
Erythema	3	3
Decreased Respiratory Rate	3	3
Unintended Extubation	3	3
Skin Discoloration	3	3
Unspecified Infection	3	3
Swelling/ Edema	2	2
Subluxation	2	2
Hypoxia	2	2
Partial thickness (Second Degree) Burn	2	2
Asphyxia	2	2
Respiratory Failure	2	2
Discomfort	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	Jun-26-2023
5	Baxter Healthcare Corporation	II	Nov-14-2022
6	Baxter Healthcare Corporation	I	Oct-31-2022
7	Hill-Rom, Inc.	II	Jul-30-2020
8	Hill-Rom, Inc.	II	Jun-03-2020
9	Linet Spol. S.r.o.	II	Jan-04-2021
10	Oakworks Inc	II	Jun-06-2022
11	Stryker Medical Division of Stryker Corporation	II	Dec-01-2023
12	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021
13	Umano Medical, Inc.	II	May-26-2022
14	Umano Medical, Inc.	II	Jun-02-2020