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	3204	3204
Unintended Movement	1528	1528
No Audible Alarm	785	992
Detachment of Device or Device Component	475	475
Electrical /Electronic Property Problem	445	2525
Incorrect Measurement	366	1476
Defective Alarm	340	340
Mechanical Problem	322	1019
Use of Device Problem	254	257
Unintended System Motion	212	552
Activation Problem	203	203
Positioning Failure	201	285
Sharp Edges	184	350
Device Fell	183	305
Intermittent Loss of Power	136	736
Sparking	125	125
Break	109	109
Adverse Event Without Identified Device or Use Problem	108	108
Appropriate Term/Code Not Available	98	98
Material Frayed	87	87
Insufficient Information	79	79
Collapse	70	70
Unclear Information	70	70
No Apparent Adverse Event	42	44
Defective Component	38	38
Circuit Failure	35	35
Patient Device Interaction Problem	32	33
Device Alarm System	31	31
Fire	28	28
Communication or Transmission Problem	25	25
Electrical Shorting	25	25
Smoking	25	24
Device Slipped	25	25
Fracture	24	24
Intermittent Continuity	21	21
Pressure Problem	20	20
Electromagnetic Interference	18	18
Defective Device	17	17
Protective Measures Problem	16	16
Entrapment of Device	16	16
Material Twisted/Bent	15	15
Component Missing	14	14
Positioning Problem	12	12
Inflation Problem	12	12
Loose or Intermittent Connection	12	12
Improper or Incorrect Procedure or Method	12	12
Arcing	12	12
Physical Resistance/Sticking	11	11
Material Integrity Problem	11	11
False Alarm	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8803	14202
Insufficient Information	440	441
Fall	374	446
Pressure Sores	156	156
No Consequences Or Impact To Patient	71	71
Bone Fracture(s)	58	58
Laceration(s)	55	60
Pain	42	67
Physical Entrapment	39	39
Hip Fracture	38	38
No Patient Involvement	30	30
Bruise/Contusion	28	31
Unspecified Tissue Injury	24	24
Electric Shock	19	30
Abrasion	17	25
Hematoma	16	16
Head Injury	15	15
Cardiac Arrest	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Skin Tears	8	8
Burn(s)	7	7
Hemorrhage/Bleeding	7	9
Strangulation	6	6
Limb Fracture	6	6
Muscle/Tendon Damage	5	5
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
Brain Injury	3	3
Loss of consciousness	3	3
Unintended Extubation	3	3
Decreased Respiratory Rate	3	3
Erythema	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
Vertebral Fracture	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