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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

Device Problems
Adverse Event Without Identified Device or Use Problem 199
Use of Device Problem 20
Insufficient Information 19
Decrease in Pressure 18
Inflation Problem 17
Deflation Problem 14
Electrical /Electronic Property Problem 9
Device Handling Problem 7
No Pressure 7
Human Factors Issue 6
Failure to Power Up 6
Computer Software Problem 6
Thermal Decomposition of Device 6
Air Leak 6
Improper or Incorrect Procedure or Method 5
Unclear Information 5
No Audible Alarm 5
Sparking 4
Fire 4
Material Separation 4
Installation-Related Problem 4
Device Issue 3
Device Operational Issue 3
No Apparent Adverse Event 3
Inadequate or Insufficient Training 3
Structural Problem 2
Detachment of Device or device Component 2
Defective Alarm 2
Off-Label Use 2
Pressure Problem 2
Loss of Power 2
Break 2
Component Falling 2
Improper Flow or Infusion 2
Power Problem 1
Use of Incorrect Control Settings 1
Material Puncture / Hole 1
Failure to Reset 1
Smoking 1
Detachment Of Device Component 1
Physical Property Issue 1
Therapeutic or Diagnostic Output Failure 1
Activation Failure Including Expansion Failures 1
Product Quality Problem 1
Unintended Movement 1
Misassembled 1
Overfill 1
Compatibility Problem 1
Material Integrity Problem 1
Unintended Electrical Shock 1
Misassembled During Installation 1
Device Inoperable 1
Circuit Failure 1
Folded 1
Increase in Pressure 1
Device Slipped 1
Device Maintenance Issue 1
Overheating of Device 1
Device-Device Incompatibility 1
Device Damaged Prior to Use 1
Defective Component 1
Total Device Problems 428

Recalls
Manufacturer Recall Class Date Posted
1 American National Mfg Inc II Aug-19-2016
2 Stryker Medical Division of Stryker Corporation II Mar-08-2016

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