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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bariatric bed
Regulation Description AC-powered adjustable hospital bed.
Definition A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.
Product CodeOSI
Regulation Number 880.5100
Device Class 2

Device Problems
Break 8
Unintended system motion 3
Use of Device Issue 3
No Known Device Problem 2
Sticking 2
Burn of device or device component 2
Collapse 1
Crack 1
Electrical issue 1
Entrapment of device or device component 1
Fire 1
Mechanical issue 1
Device emits odor 1
Bent 1
Smoking 1
Torn material 1
No Information 1
Device operates differently than expected 1
Human-Device Interface Issue 1
Total Device Problems 33

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

Recalls
Manufacturer Recall Class Date Posted
1 Kreg Medical Inc. II Jun-05-2013
2 SCM True Air Technologies LLC II May-19-2014

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