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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bed, ac-powered adjustable hospital
Product CodeFNL
Regulation Number 880.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 5887 5887
2015 3035 3035
2016 2075 2075
2017 1047 1047
2018 1214 2354
2019 1113 3114
2020 1106 2854
2021 1377 2904
2022 1118 2243
2023 2188 3258
2024 495 722

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 2975 2975
Device Slipped 2657 2668
Break 2296 2296
No Audible Alarm 1282 1486
Unintended Movement 1207 1310
Mechanical Problem 1029 2462
Material Split, Cut or Torn 889 889
Device Operates Differently Than Expected 877 877
Unintended System Motion 682 1331
Electrical /Electronic Property Problem 634 2954
Incorrect Measurement 608 3762
Device Inoperable 566 566
Bent 511 511
Defective Alarm 476 476
Detachment of Device or Device Component 433 433
Sticking 388 388
Detachment Of Device Component 293 293
Use of Device Problem 284 338
Adverse Event Without Identified Device or Use Problem 265 265
Component Missing 246 246
Self-Activation or Keying 217 217
Unintended Head Motion 186 186
Mechanics Altered 173 173
Device Fell 167 262
Sharp Edges 163 273
Improper Device Output 146 146
Scratched Material 144 144
Insufficient Information 140 140
Positioning Problem 128 136
Sparking 128 128
Intermittent Loss of Power 124 789
Appropriate Term/Code Not Available 118 118
Material Integrity Problem 109 109
False Reading From Device Non-Compliance 108 108
Naturally Worn 106 106
Activation Problem 103 103
Positioning Failure 102 161
Failure to Power Up 96 96
Loose or Intermittent Connection 95 95
Collapse 93 93
Material Frayed 90 90
Improper or Incorrect Procedure or Method 89 89
Calibration Problem 89 89
Crack 86 86
Component Falling 84 84
Defective Component 83 83
Device Stops Intermittently 79 87
Device Displays Incorrect Message 79 79
Smoking 77 76
Communication or Transmission Problem 73 73
Incorrect Or Inadequate Test Results 71 71
Unclear Information 71 71
Fire 70 70
Device Maintenance Issue 65 65
Malposition of Device 65 65
Cut In Material 58 58
Failure to Zero 52 52
Incorrect, Inadequate or Imprecise Result or Readings 42 42
Material Deformation 42 42
No Apparent Adverse Event 41 43
Delamination 40 40
Loss of Power 39 39
Entrapment of Device 38 38
Circuit Failure 38 38
Noise, Audible 38 38
Material Protrusion/Extrusion 37 37
Electrical Shorting 32 32
Thermal Decomposition of Device 31 31
Grounding Malfunction 31 31
Material Twisted/Bent 30 30
Low Audible Alarm 29 29
Unstable 28 28
Connection Problem 28 28
Intermittent Continuity 27 27
Material Separation 26 26
Defective Device 26 26
Torn Material 25 25
Patient Device Interaction Problem 24 24
Mechanical Jam 24 25
Disconnection 24 24
Melted 22 22
Device Emits Odor 22 22
Protective Measures Problem 22 22
Pressure Problem 21 21
Device Dislodged or Dislocated 19 19
Fracture 18 18
Electromagnetic Interference 18 18
Alarm Not Visible 18 24
Unintended Collision 17 17
Output Problem 17 17
Inflation Problem 16 16
Physical Resistance/Sticking 15 15
Human Factors Issue 14 14
Device Tipped Over 14 15
Arcing 14 14
Peeled/Delaminated 14 18
Inappropriate/Inadequate Shock/Stimulation 14 14
Failure to Calibrate 14 14
Out-Of-Box Failure 13 13
Failure to Sense 13 25

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 9658 9713
No Clinical Signs, Symptoms or Conditions 4380 8781
No Consequences Or Impact To Patient 2293 2566
No Patient Involvement 2208 6674
Fall 600 675
Insufficient Information 368 368
No Information 367 367
Injury 261 261
Pressure Sores 163 163
Death 127 127
Laceration(s) 117 118
Bone Fracture(s) 104 104
Pain 81 154
Physical Entrapment 81 81
Bruise/Contusion 57 61
Hip Fracture 46 46
Electric Shock 38 38
Head Injury 30 30
Abrasion 28 34
Hematoma 23 23
Unspecified Tissue Injury 20 20
Skin Tears 18 18
No Code Available 15 15
Shock 13 36
Discomfort 12 12
Burn(s) 11 11
Cardiac Arrest 11 11
Hemorrhage/Bleeding 8 8
Asphyxia 8 8
Hemorrhage, Subdural 7 7
Complaint, Ill-Defined 7 7
Low Oxygen Saturation 7 7
Swelling 7 7
Fracture, Arm 6 6
Skull Fracture 6 6
Erythema 6 6
Crushing Injury 5 5
Loss of consciousness 5 5
Limb Fracture 5 5
Blood Loss 4 4
Joint Dislocation 4 4
Anxiety 4 4
Brain Injury 4 4
Bradycardia 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Unintended Extubation 3 3
Strangulation 3 3
Tissue Damage 3 3
Intracranial Hemorrhage 3 3
Low Blood Pressure/ Hypotension 3 3
Emotional Changes 3 3
Respiratory Failure 3 3
Decreased Respiratory Rate 3 3
Patient Problem/Medical Problem 3 3
Disc Impingement 3 3
Confusion/ Disorientation 3 3
Suture Abrasion 2 2
Sleep Dysfunction 2 2
Burn, Thermal 2 2
Foreign Body In Patient 2 2
Subluxation 2 2
Muscle/Tendon Damage 2 2
Respiratory Arrest 2 2
Syncope/Fainting 2 2
Partial thickness (Second Degree) Burn 2 2
Test Result 2 2
Neck Pain 2 2
Choking 2 2
Tooth Fracture 2 2
Ulcer 2 2
Hypersensitivity/Allergic reaction 2 2
Hypoxia 2 2
Incontinence 2 2
Unspecified Infection 2 2
Muscle Spasm(s) 2 2
Muscle Weakness 2 2
Nerve Damage 2 2
Neurological Deficit/Dysfunction 2 2
Overdose 2 2
Skin Discoloration 2 2
Exposure to Body Fluids 2 2
Wound Dehiscence 2 2
Cardiopulmonary Arrest 2 2
Contusion 2 2
Dyspnea 2 2
Swelling/ Edema 2 2
Blister 2 2
Localized Skin Lesion 1 1
Skin Disorders 1 1
Contact Dermatitis 1 1
Easy Bruising 1 1
Ecchymosis 1 1
Exsanguination 1 1
Eye Injury 1 1
Diarrhea 1 1
Hair Loss 1 1
Hemorrhage, Cerebral 1 1
Headache 1 1
Hearing Impairment 1 1
Cellulitis 1 1

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 Arjo Hospital Equipment AB II Oct-06-2014
5 Arjo, Inc. dba ArjoHuntleigh II Aug-06-2013
6 Baxter Healthcare Corporation II Jun-26-2023
7 Baxter Healthcare Corporation II Nov-14-2022
8 Baxter Healthcare Corporation I Oct-31-2022
9 CHG Hospital Beds Inc II Aug-03-2016
10 CHG Hospital Beds Inc II Mar-15-2016
11 GF Health Products, Inc II Dec-12-2016
12 GF Health Products, Inc./d.b.a.Basic American Metal Products II Sep-16-2014
13 Handicare Usa Inc II Aug-20-2018
14 Hill-Rom, Inc. II Jul-30-2020
15 Hill-Rom, Inc. II Jun-03-2020
16 Hill-Rom, Inc. II Apr-09-2018
17 Hill-Rom, Inc. II Apr-12-2017
18 Hill-Rom, Inc. II Aug-09-2016
19 Hill-Rom, Inc. II Nov-13-2015
20 Hill-Rom, Inc. II Jun-26-2015
21 Hill-Rom, Inc. II Jun-05-2013
22 Hill-Rom, Inc. II Jun-22-2012
23 Hill-Rom, Inc. II Mar-07-2011
24 Hill-Rom, Inc. II Feb-11-2011
25 Hill-Rom, Inc. II Nov-09-2010
26 Hill-Rom, Inc. II Aug-24-2010
27 Hill-Rom, Inc. II Aug-03-2010
28 Hill-Rom, Inc. II Mar-11-2010
29 Hill-Rom, Inc. II Nov-18-2009
30 Hill-Rom, Inc. II May-01-2009
31 Hill-Rom, Inc. II Jan-16-2009
32 Invacare Corporation II Aug-11-2016
33 Invacare Corporation II Feb-02-2015
34 Invacare Corporation II Sep-09-2010
35 Joerns Healthcare II Oct-30-2014
36 KCI USA, Inc. II Sep-27-2012
37 Linet Americas Inc II Jan-13-2012
38 Linet Spol. S.r.o. II Jan-04-2021
39 Med-Mizer, Inc. II Sep-17-2018
40 Med-Mizer, Inc. II May-02-2014
41 Oakworks Inc II Jun-06-2022
42 Primus Medical LLC II Oct-15-2014
43 Primus Medical LLC II Nov-08-2012
44 Stryker Medical Div. of Stryker Corporation II Sep-28-2010
45 Stryker Medical Div. of Stryker Corporation II Sep-18-2009
46 Stryker Medical Div. of Stryker Corporation II Feb-25-2009
47 Stryker Medical Division of Stryker Corporation II Dec-01-2023
48 Stryker Medical Division of Stryker Corporation II Aug-06-2021
49 Stryker Medical Division of Stryker Corporation II Nov-09-2018
50 Stryker Medical Division of Stryker Corporation II Aug-08-2016
51 Stryker Medical Division of Stryker Corporation II Apr-22-2016
52 Stryker Medical Division of Stryker Corporation II Apr-22-2016
53 Stryker Medical Division of Stryker Corporation II Jul-28-2014
54 Stryker Medical Division of Stryker Corporation II Dec-31-2013
55 Stryker Medical Division of Stryker Corporation II Nov-19-2013
56 Stryker Medical Division of Stryker Corporation II Sep-26-2013
57 Stryker Medical Division of Stryker Corporation II Jan-03-2013
58 Stryker Medical Division of Stryker Corporation II Jun-22-2012
59 Stryker Medical Division of Stryker Corporation II Mar-30-2012
60 Umano Medical, Inc. II May-26-2022
61 Umano Medical, Inc. II Jun-02-2020
62 Vitalgo Inc. II Aug-09-2018
63 mobility unlimited inc II Dec-17-2013
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