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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
  1.  K771463  AERO PULSE ALTERNATING PRES. PUMP
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 28
Decrease in pressure 24
No Information 16
Burn of device or device component 13
Use of Device Issue 12
Improper or incorrect procedure or method 9
Entrapment of device or device component 8
Inflation issue 7
Deflation issue 6
Air leak 6
Electrical shorting 6
Not Applicable 5
Not audible alarm 5
Product quality issue 5
Spark 4
Device operates differently than expected 3
Human-Device Interface Issue 3
Device handling issue 3
Device inoperable 2
Misassembled by Users 2
Pressure issue 2
Improper flow or infusion 2
Patient-device incompatibility 2
Smoking 2
Fitting problem 2
Other (for use when an appropriate device code cannot be identified) 2
Replace 2
Normal 2
Overheating of device or device component 2
Peeled 2
Loss of power 2
Defective component 2
Break 2
Device alarm system issue 2
Burst 2
Detachment of device component 2
Component falling 2
Deflation, cause unknown 2
Electrical issue 2
Device maintenance issue 2
Fire 2
Mechanical issue 1
Disconnection 1
Dislodged 1
Component incompatible 1
Use of Incorrect Control Settings 1
Inaccurate delivery 1
Device Issue 1
Pressure, insufficient 1
Overfill 1
Malfunction 1
Cut in material 1
Structural problem 1
Tipover 1
Material separation 1
Unknown (for use when the device problem is not known) 1
Device damaged prior to use 1
Inadequate training 1
Detachment of device or device component 1
Incompatibility problem 1
Manufacturing or shipping issue associated with device 1
Material integrity issue 1
Device-device incompatibility 1
Foreign material present in device 1
Temperature issue 1
Therapeutic or diagnostic output failure 1
Unintended movement 1
Failure to expand 1
Total Device Problems 236

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 1 0 0 0 1 0 2
Class III 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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