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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 41
Decrease in pressure 24
No Information 17
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
Device handling issue 7
Not Applicable 6
Electrical shorting 6
Deflation issue 6
Air leak 6
Not audible alarm 5
Electrical issue 5
Product quality issue 5
Spark 5
Component falling 4
Device Issue 3
Device operates differently than expected 3
Human-Device Interface Issue 3
Improper flow or infusion 2
Patient-device incompatibility 2
Structural problem 2
Pressure issue 2
Device inoperable 2
Misassembled by Users 2
Burst 2
Detachment of device component 2
Break 2
Device alarm system issue 2
Defective Alarm 2
Deflation, cause unknown 2
Device maintenance issue 2
Fire 2
Replace 2
Normal 2
Overheating of device or device component 2
Peeled 2
Loss of power 2
Fitting problem 2
Other (for use when an appropriate device code cannot be identified) 2
Smoking 2
Device damaged prior to use 2
Defective component 2
Inaccurate delivery 1
Inadequate training 1
Unknown (for use when the device problem is not known) 1
Material separation 1
User used incorrect product for intended use 1
Mechanical issue 1
Disconnection 1
Dislodged 1
Component incompatible 1
Use of Incorrect Control Settings 1
Failure to expand 1
Temperature issue 1
Therapeutic or diagnostic output failure 1
Unintended movement 1
Foreign material present in device 1
Power source issue 1
Tipover 1
Folded 1
Pressure, insufficient 1
Overfill 1
Malfunction 1
Cut in material 1
Detachment of device or device component 1
Device-device incompatibility 1
Incompatibility problem 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Total Device Problems 276

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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