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	4080	4080
Unintended Movement	1823	1823
No Audible Alarm	845	1059
Electrical /Electronic Property Problem	652	2732
Detachment of Device or Device Component	508	508
Incorrect Measurement	365	1475
Defective Alarm	340	340
Mechanical Problem	337	1034
Positioning Failure	322	406
Use of Device Problem	280	283
Activation Problem	259	259
Unintended System Motion	224	567
Device Fell	201	337
Sharp Edges	200	382
Intermittent Loss of Power	136	736
Sparking	133	133
Adverse Event Without Identified Device or Use Problem	115	115
Break	106	106
Appropriate Device Problem Term/Code Not Available	101	101
Material Frayed	100	100
Insufficient Device Problem Information	97	97
Collapse	82	82
Unclear Information	70	70
No Apparent Adverse Event	52	54
Fracture	46	46
Material Twisted/Bent	36	36
Circuit Failure	35	35
Patient Device Interaction Problem	34	37
Communication or Transmission Problem	26	26
Fire	25	25
Defective Component	25	25
Intermittent Continuity	24	24
Electrical Shorting	23	23
Pressure Problem	20	20
Device Alarm System	20	20
Electromagnetic Interference	18	18
Entrapment of Device	17	17
Smoking	17	16
Component Missing	15	15
Power Problem	14	14
Positioning Problem	14	14
Defective Device	14	14
Arcing	13	13
Material Integrity Problem	13	13
Flare or Flash	12	12
Noise, Audible	12	12
Loose or Intermittent Connection	12	12
Improper or Incorrect Procedure or Method	12	12
Mechanical Jam	12	12
Inflation Problem	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10750	16189
Insufficient Information	452	453
Fall	421	499
Pressure Sore/Ulcer	158	158
No Consequences Or Impact To Patient	71	71
Bone Fracture(s)	68	68
Laceration(s)	59	65
Pain	45	70
Physical Entrapment	43	44
Hip Fracture	42	42
No Patient Involvement	30	30
Bruise/Contusion	30	33
Unspecified Tissue Injury	28	28
Electric Shock	19	30
Abrasion	18	26
Hematoma	17	17
Head Injury	16	16
Cardiac Arrest	12	12
Strangulation	9	9
Limb Fracture	9	9
Skin Tears	9	9
Burn(s)	8	8
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	8	8
Hemorrhage/Blood Loss/Bleeding	7	9
Respiratory Arrest	5	5
Muscle/Tendon Damage	5	5
Brain Injury	4	4
Convulsion/Seizure	4	4
Low Blood Pressure/ Hypotension	4	4
Low Oxygen Saturation	4	4
Vertebral Fracture	4	4
Discomfort	4	4
Hypoxia	3	3
Skull Fracture	3	3
Multiple Fractures	3	3
Loss of consciousness	3	3
Shock	3	9
Apnea	3	3
Decreased Respiratory Rate	3	3
Unintended Extubation	3	3
Unspecified Infection	3	3
Erythema	3	3
Partial thickness (Second Degree) Burn	2	2
Ulcer	2	2
Swelling/ Edema	2	2
Headache	2	2
Limb Pain	2	2
Subluxation	2	2
Bradycardia	2	2
Respiratory Failure	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	Baxter Healthcare Corporation	II	Oct-25-2024
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	KAYSERBETTEN GMBH & CO. KG	I	Jun-04-2026
8	Linet Spol. S.r.o.	II	Jan-04-2021
9	Oakworks Inc	II	Jun-06-2022
10	Stryker Medical Division of Stryker Corporation	II	Dec-01-2023
11	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021
12	Umano Medical, Inc.	II	May-26-2022