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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device mattress, air flotation, alternating pressure
Regulation Description Alternating pressure air flotation mattress.
Product CodeFNM
Regulation Number 880.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIO SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
INVACARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 8
LUMEX
  SUBSTANTIALLY EQUIVALENT 3
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
PLEXUS BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
SKYTRON
  SUBSTANTIALLY EQUIVALENT 1
SPAN-AMERICA MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TALLEY GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
WHEELCHAIRS OF KANSAS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 60
Decrease in pressure 24
Use of Device Issue 20
No Information 18
Improper or incorrect procedure or method 13
Burn of device or device component 13
Air leak 10
Inflation issue 8
Entrapment of device or device component 8
Device handling issue 8
Not Applicable 6
Electrical shorting 6
Spark 6
Deflation issue 6
Electrical issue 5
Not audible alarm 5
Product quality issue 5
Fire 4
Component falling 4
Device maintenance issue 3
Smoking 3
Device operates differently than expected 3
Device Issue 3
Human-Device Interface Issue 3
Pressure issue 3
Misassembled by Users 2
Improper flow or infusion 2
Material separation 2
Device inoperable 2
Device damaged prior to use 2
Defective component 2
Patient-device incompatibility 2
Structural problem 2
Replace 2
Fitting problem 2
Other (for use when an appropriate device code cannot be identified) 2
Normal 2
Overheating of device or device component 2
Peeled 2
Loss of power 2
Deflation, cause unknown 2
Burst 2
Detachment of device component 2
Break 2
Device alarm system issue 2
Defective Alarm 2
Component incompatible 1
Use of Incorrect Control Settings 1
Disconnection 1
Dislodged 1
Mechanical issue 1
Misassembled 1
User used incorrect product for intended use 1
Unknown (for use when the device problem is not known) 1
Failure to reset 1
Inadequate training 1
Tipover 1
Folded 1
Detachment of device or device component 1
Device-device incompatibility 1
Inaccurate delivery 1
Pressure, insufficient 1
Overfill 1
Malfunction 1
Cut in material 1
Incompatibility problem 1
Installation-related problem 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Foreign material present in device 1
Power source issue 1
Failure to expand 1
Temperature issue 1
Therapeutic or diagnostic output failure 1
Unintended movement 1
Total Device Problems 318

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 0 0 1 1 0 0 0 1 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 American National Mfg Inc II Aug-19-2016
2 Encompass Therapeutic Support Systems dba BG North America II Mar-31-2010
3 Hill-Rom Manufacturing, Inc. II Jan-07-2009
4 SCM True Air Technologies LLC II May-19-2014
5 Stryker Medical Division of Stryker Corporation II Mar-08-2016

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