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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lift, patient, non-ac-powered
Product CodeFSA
Regulation Number 880.5510
Device Class 1

MDR Year MDR Reports MDR Events
2014 1602 1602
2015 1421 1421
2016 735 735
2017 378 378
2018 367 367
2019 393 393
2020 281 281
2021 257 257
2022 264 264
2023 342 342
2024 236 236

Device Problems MDRs with this Device Problem Events in those MDRs
Break 985 985
Detachment of Device or Device Component 673 673
Use of Device Problem 551 551
Device Operates Differently Than Expected 474 474
Detachment Of Device Component 433 433
Mechanical Problem 393 393
Adverse Event Without Identified Device or Use Problem 288 288
Device Tipped Over 267 267
Bent 248 248
Unintended Movement 230 230
Device Slipped 171 171
Leak/Splash 159 159
Component Falling 153 153
Insufficient Information 143 143
Crack 129 129
Device Inoperable 98 98
Device Handling Problem 97 97
Device Fell 96 96
Loose or Intermittent Connection 92 92
Improper or Incorrect Procedure or Method 83 83
Fracture 81 81
Sticking 74 74
Component Missing 74 74
Unintended System Motion 73 73
Unstable 72 72
Torn Material 70 70
Material Separation 65 65
Material Split, Cut or Torn 65 65
Naturally Worn 58 58
Appropriate Term/Code Not Available 57 57
Fluid/Blood Leak 56 56
Material Integrity Problem 55 55
Noise, Audible 55 55
Installation-Related Problem 44 44
Material Deformation 43 43
Inadequate or Insufficient Training 42 42
Material Frayed 41 41
Mechanics Altered 41 41
Device Dislodged or Dislocated 34 34
Material Rupture 32 32
Material Twisted/Bent 29 29
Sparking 29 29
Out-Of-Box Failure 29 29
Human Factors Issue 25 25
Device Stops Intermittently 25 25
Defective Component 25 25
Electrical /Electronic Property Problem 24 24
Thermal Decomposition of Device 22 22
Battery Problem 21 21
Malposition of Device 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2315 2316
Fall 1353 1353
No Consequences Or Impact To Patient 753 753
No Clinical Signs, Symptoms or Conditions 459 459
Bone Fracture(s) 403 403
Head Injury 286 286
Bruise/Contusion 273 273
Laceration(s) 240 240
No Information 240 240
No Patient Involvement 192 192
Injury 188 188
Pain 150 152
Death 140 140
Hematoma 100 100
Hip Fracture 59 59
Skin Tears 54 54
Abrasion 50 50
Insufficient Information 49 49
Not Applicable 49 49
Contusion 36 36
Fracture, Arm 26 26
Concussion 26 26
No Code Available 25 25
Hemorrhage/Bleeding 23 23
Limb Fracture 19 19
Swelling 18 20
Electric Shock 15 15
Sprain 15 15
Physical Entrapment 14 14
Unspecified Tissue Injury 14 14
Intracranial Hemorrhage 13 13
Patient Problem/Medical Problem 13 13
Multiple Fractures 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Muscle/Tendon Damage 10 10
Skull Fracture 10 10
Discomfort 9 9
Pressure Sores 9 9
Swelling/ Edema 8 8
Hemorrhage, Cerebral 8 8
Headache 8 8
Joint Dislocation 7 7
Complaint, Ill-Defined 7 7
Vertebral Fracture 7 7
Neck Pain 7 7
Tissue Damage 5 5
Brain Injury 5 5
Rupture 5 5
Tooth Fracture 5 5
Suture Abrasion 5 5

Recalls
Manufacturer Recall Class Date Posted
1 ARJOHUNTLEIGH POLSKA SP. ZO.O. II Sep-16-2014
2 ARJOHUNTLEIGH POLSKA Sp. z.o.o. I May-21-2022
3 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Mar-06-2020
4 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Dec-07-2018
5 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Sep-24-2014
6 Arjo, Inc. II Jan-30-2009
7 Arjo, Inc. dba ArjoHuntleigh II Apr-14-2016
8 Arjo, Inc. dba ArjoHuntleigh II Oct-17-2014
9 Arjo, Inc. dba ArjoHuntleigh II Jul-06-2012
10 Arjo, Inc. dba ArjoHuntleigh II Aug-24-2011
11 Arjo, Inc. dba ArjoHuntleigh II Apr-14-2011
12 ArjoHuntleigh II Sep-22-2009
13 ArjoHuntleigh II Sep-08-2009
14 ArjoHuntleigh II Aug-27-2009
15 ArjoHuntleigh II Jul-24-2009
16 Arjohuntleigh Magog II Aug-07-2018
17 Arjohuntleigh Magog, Inc. II May-24-2023
18 Arjohuntleigh Magog, Inc. II Sep-16-2021
19 Arjohuntleigh Magog, Inc. II Feb-09-2021
20 Autochair II Apr-18-2018
21 Baxter Healthcare Corporation II Mar-28-2022
22 Community Products, LLC II Oct-22-2019
23 ErgoSafe Product LLC dba Prism Medical Services II Apr-10-2014
24 ErgoSafe Products, LLC (DBA) Prism Medical II Feb-28-2017
25 ErgoSafe Products, LLC (DBA) Prism Medical II Dec-09-2016
26 ErgoSafe Products, LLC (DBA) Prism Medical II Nov-17-2015
27 ErgoSafe Products, LLC (DBA) Prism Medical II Jul-27-2015
28 Ergosafe Products LLC DBA Prism Medical Services USA II Nov-20-2013
29 Getinge Dominican Republic SA II Sep-13-2021
30 Handicare AB II Oct-09-2020
31 Handicare AB II May-09-2020
32 Handicare AB II Oct-11-2017
33 Handicare Accessibility II Nov-06-2013
34 Handicare Usa Inc II Sep-15-2017
35 Hill-Rom, Inc. II Mar-11-2022
36 Hill-Rom, Inc. II Feb-16-2022
37 Hill-Rom, Inc. II Sep-30-2021
38 Hill-Rom, Inc. I Jan-29-2021
39 Hill-Rom, Inc. II Oct-31-2016
40 Hill-Rom, Inc. II Jun-07-2016
41 Hill-Rom, Inc. II Jun-19-2015
42 Hill-Rom, Inc. II Jun-05-2013
43 Hill-Rom, Inc. II Feb-21-2013
44 Hill-Rom, Inc. II Dec-31-2012
45 Hill-Rom, Inc. II Mar-17-2011
46 Hill-Rom, Inc. II Feb-23-2011
47 Human Care Hc Sweden Ab II Apr-05-2024
48 Human Care USA, Inc. II Mar-31-2022
49 Invacare Corporation II Dec-03-2018
50 KCI USA, Inc. II Apr-16-2012
51 Liko AB II Oct-12-2018
52 Liko North America Inc II Jan-27-2009
53 Med-Mizer, Inc. II Mar-02-2023
54 Moller Vital II May-16-2019
55 Moller Vital II Jul-26-2016
56 Moller Vital II May-21-2013
57 Prism Medical Services USA II Jun-19-2013
58 Romedic, Inc. II Jun-01-2010
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