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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, bed patient
Regulation Description Bed-patient monitor.
Product CodeKMI
Regulation Number 880.2400
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
AFRAME DIGITAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BED-CHECK CORP.
  SUBSTANTIALLY EQUIVALENT 1
BERCHTOLD CORP.
  SUBSTANTIALLY EQUIVALENT 1
J. T. POSEY CO.
  SUBSTANTIALLY EQUIVALENT 1
STANLEY
  SUBSTANTIALLY EQUIVALENT 1
TACTILITES, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device alarm system issue 510
Failure to power-up 187
Unknown (for use when the device problem is not known) 148
Alarm, intermittent 136
Other (for use when an appropriate device code cannot be identified) 110
Failure to sense 76
Not audible alarm 70
False alarm 45
Loss of power 30
Loose or intermittent connection 27
Failure to reset 15
Improper alarm 14
No Information 13
Device Issue 11
Fitting problem 10
Low audible alarm 10
Corrosion 8
Device stops intermittently 7
Wire(s), breakage of 6
Component falling 6
Component(s), broken 5
Alarm, failure of warning 5
Inaudible voice prompts 5
No Known Device Problem 5
Fail-safe mechanism issue 4
Sensing intermittently 4
Display misread 4
Loose 3
Delayed alarm 3
Defective Alarm 3
Detachment of device component 3
Alarm not visible 3
Low battery 3
Device damaged prior to use 3
Device inoperable 3
Use of Device Issue 3
Volume accuracy issue 2
Cable, defective 2
Device operates differently than expected 2
Protective measure issue 2
Continuous 2
Crack 2
Battery failure 2
Break 2
Function indicator light(s), failure of 2
Sensor problems 2
Mechanical issue 2
Potentiometer readings, high 1
No display or display failure 1
Incorrect display 1
Shock, electrical 1
Electrical issue 1
Fail-safe design failure 1
Failure, intermittent 1
Precision 1
Pressure sensor failure 1
Circuit Failure 1
Failure to deploy 1
No code available 1
Decreased sensitivity 1
Close, difficult to 1
Battery issue 1
Communication or transmission issue 1
Connection issue 1
Component missing 1
Invalid sensing 1
Electrical wires, defective 1
Undersensing 1
No voice prompts 1
Total Device Problems 1542

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 1 1 2 1 3 2 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AliMed Corporation II Apr-16-2010
2 Curbell Medical, Inc. II Aug-26-2014
3 Hoana Medical II Jan-24-2008
4 Intel-GE Care Innovations LLC II Feb-23-2013
5 RF Technologies, Inc. II Jun-26-2013
6 Richard Wolf Medical Instruments Corp. II Mar-03-2015
7 Stanley Security Solutions, Inc. II Sep-28-2012
8 Stanley Security Solutions, Inc. II Apr-28-2012
9 Stanley Security Solutions, Inc. II Apr-27-2012
10 Stanley Security Solutions, Inc. II Mar-31-2011
11 Stanley Security Solutions, Inc. II Jul-01-2010
12 Sterilmed Inc II Jan-13-2009

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