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	3523	3523
Unintended Movement	1674	1674
No Audible Alarm	821	1031
Detachment of Device or Device Component	489	489
Electrical /Electronic Property Problem	447	2527
Incorrect Measurement	366	1476
Defective Alarm	345	345
Mechanical Problem	323	1020
Use of Device Problem	267	270
Positioning Failure	261	345
Activation Problem	229	229
Unintended System Motion	216	556
Device Fell	197	329
Sharp Edges	192	368
Intermittent Loss of Power	136	736
Sparking	134	134
Adverse Event Without Identified Device or Use Problem	112	112
Break	110	110
Collapse	100	100
Appropriate Term/Code Not Available	99	99
Material Frayed	88	88
Insufficient Information	84	84
Unclear Information	70	70
No Apparent Adverse Event	50	52
Defective Component	39	39
Circuit Failure	36	36
Patient Device Interaction Problem	33	35
Device Alarm System	31	31
Fire	29	29
Fracture	27	27
Smoking	26	25
Communication or Transmission Problem	26	26
Electrical Shorting	25	25
Device Slipped	25	25
Intermittent Continuity	23	23
Pressure Problem	20	20
Entrapment of Device	18	18
Electromagnetic Interference	18	18
Defective Device	17	17
Protective Measures Problem	16	16
Material Twisted/Bent	16	16
Component Missing	14	14
Inflation Problem	13	13
Improper or Incorrect Procedure or Method	13	13
Loose or Intermittent Connection	12	12
Arcing	12	12
Positioning Problem	12	12
Material Integrity Problem	11	11
Physical Resistance/Sticking	11	11
Melted	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9475	14898
Insufficient Information	442	443
Fall	397	472
Pressure Sores	158	158
No Consequences Or Impact To Patient	71	71
Bone Fracture(s)	63	63
Laceration(s)	56	62
Pain	43	68
Physical Entrapment	41	41
Hip Fracture	39	39
No Patient Involvement	30	30
Unspecified Tissue Injury	28	28
Bruise/Contusion	28	31
Electric Shock	19	30
Hematoma	17	17
Abrasion	17	25
Head Injury	15	15
Cardiac Arrest	11	11
Skin Tears	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Burn(s)	8	8
Strangulation	7	7
Hemorrhage/Bleeding	7	9
Limb Fracture	6	6
Muscle/Tendon Damage	5	5
Vertebral Fracture	4	4
Discomfort	4	4
Brain Injury	4	4
Low Oxygen Saturation	4	4
Shock	3	9
Erythema	3	3
Hypoxia	3	3
Loss of consciousness	3	3
Multiple Fractures	3	3
Skull Fracture	3	3
Respiratory Arrest	3	3
Decreased Respiratory Rate	3	3
Unintended Extubation	3	3
Unspecified Infection	3	3
Rupture	2	2
Blister	2	2
Unspecified Musculoskeletal problem	2	2
Headache	2	2
Skin Discoloration	2	2
Confusion/ Disorientation	2	2
Convulsion/Seizure	2	2
Partial thickness (Second Degree) Burn	2	2
Low Blood Pressure/ Hypotension	2	2
Intracranial Hemorrhage	2	2
Neck Pain	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