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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
Regulation Description AC-powered adjustable hospital bed.
Product CodeFNL
Regulation Number 880.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
CARROLL HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 5
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
JOERNS HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
M.C. HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
SSC MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
VAIL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Side rails, failure of 2237
Repair 1641
Loose 1603
Slippage of device or device component 660
Sticking 420
Unintended system motion 401
Break 330
Device inoperable 303
Other (for use when an appropriate device code cannot be identified) 289
Device alarm system issue 280
Mechanical issue 269
Unintended head motion 249
Electrical issue 161
Replace 147
No Information 147
Grounding malfunction 140
Detachment of device component 99
Device operates differently than expected 87
Tears, rips, holes in device, device material 85
No Known Device Problem 83
Moisture damage 71
Contamination during use 61
No code available 56
Insulation degradation 53
Unintended movement 47
Manufacturing or shipping issue associated with device 43
Solder joint failure 42
Use of Device Issue 39
Unknown (for use when the device problem is not known) 38
Bent 31
Corrosion 28
Material integrity issue 27
Arcing 26
Collapse 22
Locking mechanism failure 22
Component missing 21
Component falling 20
Naturally worn 19
Electrical shorting 18
Loss of power 16
Material separation 16
Difficult to position 15
Cut in material 14
Device Issue 13
Device displays error message 13
Dislodged or dislocated 12
Component(s), broken 12
Entrapment of device or device component 11
Failure to power-up 11
Fracture 11
Motor failure 11
Device stops intermittently 9
Unstable 9
Device maintenance issue 9
Loose or intermittent connection 9
Spark 8
No display or display failure 7
Positioning Issue 7
Inadequate training 7
Device handling issue 6
Delayed alarm 6
Foreign material present in device 6
Difficult or delayed activation 6
Smoking 6
Human-Device Interface Issue 6
Product quality issue 6
Improper or incorrect procedure or method 6
Device contamination with blood or blood product 5
Foreign material 5
Self-activation or keying 5
Malfunction 5
Device damaged prior to use 5
Close, difficult to 5
Torn material 5
Detachment of device or device component 5
Crack 5
Hole in material 5
User used incorrect product for intended use 4
Disengaged 4
Calibration error 4
Burn of device or device component 4
Material frayed 4
Circuit Failure 4
Delamination 4
Not audible alarm 4
Failure to calibrate 4
Device sensing issue 4
Power source issue 3
Migration of device or device component 3
Tipover 3
Misassembled 3
Device remains activated 3
Mechanics altered 3
Scratched material 3
Defective item 3
Device emits odor 3
Misassembled by Users 2
Cable break 2
Protective measure issue 2
Peeled 2
Total Device Problems 10708

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 3 5 6 2 6 7 6 3 8 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Arjo Hospital Equipment AB II Oct-06-2014
2 Arjo, Inc. dba ArjoHuntleigh II Aug-06-2013
3 CHG Hospital Beds Inc II Aug-03-2016
4 CHG Hospital Beds Inc II Mar-15-2016
5 GF Health Products, Inc II Dec-12-2016
6 GF Health Products, Inc./d.b.a.Basic American Metal Products II Sep-16-2014
7 Hill-Rom, Inc. II Aug-09-2016
8 Hill-Rom, Inc. II Nov-13-2015
9 Hill-Rom, Inc. II Jun-26-2015
10 Hill-Rom, Inc. II Jun-05-2013
11 Hill-Rom, Inc. II Jun-22-2012
12 Hill-Rom, Inc. II Mar-07-2011
13 Hill-Rom, Inc. II Feb-11-2011
14 Hill-Rom, Inc. II Nov-09-2010
15 Hill-Rom, Inc. II Aug-24-2010
16 Hill-Rom, Inc. II Aug-03-2010
17 Hill-Rom, Inc. II Mar-11-2010
18 Hill-Rom, Inc. II Nov-18-2009
19 Hill-Rom, Inc. II May-01-2009
20 Hill-Rom, Inc. II Jan-16-2009
21 Hill-Rom, Inc. II Sep-05-2008
22 Hill-Rom, Inc. II Aug-27-2008
23 Invacare Corporation II Aug-11-2016
24 Invacare Corporation II Feb-02-2015
25 Invacare Corporation II Sep-09-2010
26 Joerns Healthcare II Oct-30-2014
27 KCI USA, Inc. II Sep-27-2012
28 Linet Americas Inc II Jan-13-2012
29 Med-Mizer, Inc. II May-02-2014
30 Primus Medical LLC II Oct-15-2014
31 Primus Medical LLC II Nov-08-2012
32 Stryker Medical Div. of Stryker Corporation II Sep-28-2010
33 Stryker Medical Div. of Stryker Corporation II Sep-18-2009
34 Stryker Medical Div. of Stryker Corporation II Feb-25-2009
35 Stryker Medical Div. of Stryker Corporation II Sep-19-2008
36 Stryker Medical Div. of Stryker Corporation II Dec-08-2007
37 Stryker Medical Division of Stryker Corporation II Aug-08-2016
38 Stryker Medical Division of Stryker Corporation II Apr-22-2016
39 Stryker Medical Division of Stryker Corporation II Apr-22-2016
40 Stryker Medical Division of Stryker Corporation II Jul-28-2014
41 Stryker Medical Division of Stryker Corporation II Dec-31-2013
42 Stryker Medical Division of Stryker Corporation II Nov-19-2013
43 Stryker Medical Division of Stryker Corporation II Sep-26-2013
44 Stryker Medical Division of Stryker Corporation II Jan-03-2013
45 Stryker Medical Division of Stryker Corporation II Jun-22-2012
46 Stryker Medical Division of Stryker Corporation II Mar-30-2012
47 mobility unlimited inc II Dec-17-2013

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