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	3300	3300
Unintended Movement	1561	1561
No Audible Alarm	798	1005
Detachment of Device or Device Component	480	480
Electrical /Electronic Property Problem	446	2526
Incorrect Measurement	366	1476
Defective Alarm	342	342
Mechanical Problem	322	1019
Use of Device Problem	257	260
Positioning Failure	224	308
Unintended System Motion	212	552
Activation Problem	212	212
Device Fell	192	315
Sharp Edges	185	351
Intermittent Loss of Power	136	736
Sparking	129	129
Adverse Event Without Identified Device or Use Problem	109	109
Break	109	109
Appropriate Term/Code Not Available	98	98
Collapse	93	93
Material Frayed	87	87
Insufficient Information	80	80
Unclear Information	70	70
No Apparent Adverse Event	46	48
Defective Component	38	38
Circuit Failure	35	35
Patient Device Interaction Problem	32	33
Device Alarm System	31	31
Fire	28	28
Electrical Shorting	25	25
Communication or Transmission Problem	25	25
Device Slipped	25	25
Smoking	25	24
Fracture	24	24
Intermittent Continuity	22	22
Pressure Problem	20	20
Electromagnetic Interference	18	18
Defective Device	17	17
Entrapment of Device	16	16
Protective Measures Problem	16	16
Material Twisted/Bent	15	15
Component Missing	14	14
Inflation Problem	12	12
Loose or Intermittent Connection	12	12
Positioning Problem	12	12
Improper or Incorrect Procedure or Method	12	12
Arcing	12	12
Material Integrity Problem	11	11
Physical Resistance/Sticking	11	11
False Alarm	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9018	14418
Insufficient Information	441	442
Fall	381	453
Pressure Sores	156	156
No Consequences Or Impact To Patient	71	71
Bone Fracture(s)	58	58
Laceration(s)	55	60
Pain	43	68
Physical Entrapment	39	39
Hip Fracture	38	38
No Patient Involvement	30	30
Bruise/Contusion	28	31
Unspecified Tissue Injury	27	27
Electric Shock	19	30
Abrasion	17	25
Hematoma	17	17
Head Injury	15	15
Cardiac Arrest	10	10
Skin Tears	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Burn(s)	7	7
Hemorrhage/Bleeding	7	9
Strangulation	6	6
Limb Fracture	6	6
Muscle/Tendon Damage	5	5
Brain Injury	4	4
Low Oxygen Saturation	4	4
Discomfort	4	4
Skull Fracture	3	3
Respiratory Arrest	3	3
Hypoxia	3	3
Multiple Fractures	3	3
Shock	3	9
Loss of consciousness	3	3
Unintended Extubation	3	3
Decreased Respiratory Rate	3	3
Erythema	3	3
Vertebral Fracture	3	3
Unspecified Infection	3	3
Ulcer	2	2
Convulsion/Seizure	2	2
Swelling/ Edema	2	2
Partial thickness (Second Degree) Burn	2	2
Subluxation	2	2
Bradycardia	2	2
Headache	2	2
Low Blood Pressure/ Hypotension	2	2
Exposure to Body Fluids	2	2
Respiratory Failure	2	2
Full thickness (Third 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	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	Linet Spol. S.r.o.	II	Jan-04-2021
8	Oakworks Inc	II	Jun-06-2022
9	Stryker Medical Division of Stryker Corporation	II	Dec-01-2023
10	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021
11	Umano Medical, Inc.	II	May-26-2022