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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 1474 2168

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 2975 2975
Device Slipped 2658 2669
Break 2296 2296
Material Split, Cut or Torn 1378 1378
No Audible Alarm 1321 1536
Unintended Movement 1317 1420
Mechanical Problem 1049 2521
Device Operates Differently Than Expected 877 877
Unintended System Motion 698 1357
Electrical /Electronic Property Problem 685 3224
Incorrect Measurement 639 3858
Device Inoperable 566 566
Bent 511 511
Detachment of Device or Device Component 485 485
Defective Alarm 478 478
Sticking 388 388
Use of Device Problem 307 361
Detachment Of Device Component 293 293
Adverse Event Without Identified Device or Use Problem 270 270
Component Missing 247 247
Self-Activation or Keying 217 217
Unintended Head Motion 186 186
Device Fell 184 295
Sharp Edges 180 306
Mechanics Altered 173 173
Improper Device Output 146 146
Scratched Material 144 144
Insufficient Information 143 143
Intermittent Loss of Power 137 888
Sparking 134 134
Positioning Problem 129 137
Appropriate Term/Code Not Available 124 124
Positioning Failure 122 186
Activation Problem 118 118
Material Integrity Problem 109 109
False Reading From Device Non-Compliance 108 108
Naturally Worn 106 106
Failure to Power Up 96 96
Loose or Intermittent Connection 95 95
Material Frayed 95 95
Collapse 93 93
Improper or Incorrect Procedure or Method 89 89
Calibration Problem 89 89
Crack 86 86
Component Falling 84 84
Defective Component 83 83
Smoking 80 79
Device Displays Incorrect Message 79 79
Device Stops Intermittently 79 87
Communication or Transmission Problem 74 74

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 5281 10149
No Consequences Or Impact To Patient 2293 2566
No Patient Involvement 2208 6674
Fall 628 710
Insufficient Information 390 390
No Information 367 367
Injury 261 261
Pressure Sores 167 167
Death 127 127
Laceration(s) 123 124
Bone Fracture(s) 111 111
Physical Entrapment 82 82
Pain 82 155
Bruise/Contusion 61 65
Hip Fracture 46 46
Electric Shock 38 38
Head Injury 34 34
Abrasion 30 36
Hematoma 25 25
Unspecified Tissue Injury 23 23
Skin Tears 18 18
No Code Available 15 15
Shock 13 36
Discomfort 13 13
Cardiac Arrest 12 12
Burn(s) 11 11
Hemorrhage/Bleeding 10 10
Asphyxia 8 8
Hemorrhage, Subdural 7 7
Swelling 7 7
Low Oxygen Saturation 7 7
Complaint, Ill-Defined 7 7
Skull Fracture 6 6
Erythema 6 6
Fracture, Arm 6 6
Brain Injury 5 5
Loss of consciousness 5 5
Joint Dislocation 5 5
Crushing Injury 5 5
Limb Fracture 5 5
Anxiety 4 4
Blood Loss 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Bradycardia 4 4
Unspecified Infection 4 4
Respiratory Failure 3 3
Low Blood Pressure/ Hypotension 3 3
Decreased Respiratory Rate 3 3
Emotional Changes 3 3

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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