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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 36
Decrease in pressure 24
No Information 16
Use of Device Issue 15
Burn of device or device component 13
Improper or incorrect procedure or method 12
Entrapment of device or device component 8
Inflation issue 7
Deflation issue 6
Electrical shorting 6
Air leak 6
Device handling issue 6
Not Applicable 5
Not audible alarm 5
Electrical issue 5
Spark 5
Product quality issue 5
Component falling 4
Device Issue 3
Human-Device Interface Issue 3
Device operates differently than expected 3
Burst 2
Patient-device incompatibility 2
Fire 2
Device inoperable 2
Defective component 2
Replace 2
Smoking 2
Structural problem 2
Loss of power 2
Misassembled by Users 2
Pressure issue 2
Detachment of device component 2
Normal 2
Device maintenance issue 2
Fitting problem 2
Peeled 2
Deflation, cause unknown 2
Defective Alarm 2
Device alarm system issue 2
Device damaged prior to use 2
Overheating of device or device component 2
Break 2
Other (for use when an appropriate device code cannot be identified) 2
Improper flow or infusion 2
Inaccurate delivery 1
Temperature issue 1
Detachment of device or device component 1
Mechanical issue 1
Cut in material 1
Malfunction 1
Manufacturing or shipping issue associated with device 1
Disconnection 1
Dislodged 1
Device-device incompatibility 1
Unintended movement 1
Foreign material present in device 1
Material separation 1
Component incompatible 1
Use of Incorrect Control Settings 1
Inadequate training 1
User used incorrect product for intended use 1
Folded 1
Therapeutic or diagnostic output failure 1
Tipover 1
Overfill 1
Unknown (for use when the device problem is not known) 1
Pressure, insufficient 1
Failure to expand 1
Incompatibility problem 1
Material integrity issue 1
Power source issue 1
Total Device Problems 268

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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