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	2806	2806
Unintended Movement	1554	1573
No Audible Alarm	1111	1359
Electrical /Electronic Property Problem	586	3294
Detachment of Device or Device Component	566	566
Incorrect Measurement	541	3381
Mechanical Problem	470	1802
Defective Alarm	374	374
Device Alarm System	364	364
Unintended System Motion	351	981
Use of Device Problem	303	303
Sharp Edges	222	401
Device Fell	221	372
Activation Problem	191	191
Intermittent Loss of Power	168	1069
Positioning Failure	155	252
Device Slipped	153	153
Adverse Event Without Identified Device or Use Problem	136	137
Break	126	163
Sparking	123	123
Appropriate Term/Code Not Available	103	103
Material Frayed	87	87
Insufficient Information	83	83
Unclear Information	71	71
Defective Component	61	61
Collapse	52	52
Self-Activation or Keying	47	47
No Apparent Adverse Event	45	47
Fire	43	43
Loose or Intermittent Connection	42	42
Communication or Transmission Problem	36	36
Patient Device Interaction Problem	35	35
Circuit Failure	34	34
Smoking	32	32
Positioning Problem	31	39
Electrical Shorting	29	29
Fracture	22	22
Defective Device	22	22
Material Twisted/Bent	21	21
Intermittent Continuity	21	21
Pressure Problem	20	20
Improper or Incorrect Procedure or Method	18	18
Electromagnetic Interference	18	18
Entrapment of Device	17	17
Component Missing	16	16
Protective Measures Problem	15	15
Inflation Problem	14	14
Physical Resistance/Sticking	14	14
Arcing	14	14
Failure to Sense	13	23

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8181	14003
No Patient Involvement	1691	5017
Fall	437	531
Insufficient Information	436	437
No Consequences Or Impact To Patient	265	363
Pressure Sores	159	159
No Known Impact Or Consequence To Patient	91	129
Laceration(s)	80	84
Bone Fracture(s)	78	78
Pain	49	122
Hip Fracture	43	43
Physical Entrapment	40	40
Bruise/Contusion	37	41
Death	30	31
Unspecified Tissue Injury	24	24
Electric Shock	23	34
Abrasion	21	27
Head Injury	21	21
Hematoma	17	17
Injury	14	14
Cardiac Arrest	11	11
Hemorrhage/Bleeding	8	8
Burn(s)	8	8
Skin Tears	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Limb Fracture	6	6
Strangulation	6	6
Muscle/Tendon Damage	5	5
Shock	5	28
Hemorrhage, Subdural	5	5
Bradycardia	4	4
Joint Dislocation	4	4
Skull Fracture	4	4
Discomfort	4	4
Loss of consciousness	4	4
Low Oxygen Saturation	4	4
Partial thickness (Second Degree) Burn	3	3
Low Blood Pressure/ Hypotension	3	3
Erythema	3	3
Decreased Respiratory Rate	3	3
Skin Discoloration	3	3
Unintended Extubation	3	3
Unspecified Infection	3	3
Brain Injury	3	3
Blister	3	3
No Code Available	3	3
Respiratory Arrest	3	3
Multiple Fractures	3	3
Hypersensitivity/Allergic reaction	2	2
Swelling/ Edema	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