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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, ph, stomach
Regulation Description Stomach pH electrode.
Product CodeFFT
Regulation Number 876.1400
Device Class 1

Device Problems
Failure To Adhere Or Bond 1849
Positioning Failure 400
Loss of or Failure to Bond 326
Communication or Transmission Problem 148
Detachment Of Device Component 103
Detachment of Device or device Component 94
Device Operates Differently Than Expected 72
Failure to Transmit Record 65
Adverse Event Without Identified Device or Use Problem 58
Entrapment of Device 57
Difficult or Delayed Positioning 39
Unintended Application Program Shut Down 31
Signal Artifact 25
High pH 24
Insufficient Information 22
Missing Test Results 20
Device Displays Incorrect Message 19
Failure to Calibrate 11
Poor Quality Image 11
Data Problem 10
Misconnection 9
Loss of Data 9
Loss of Power 8
Failure to Power Up 6
Incorrect, Inadequate or Imprecise Result or Readings 6
Separation Failure 5
Invalid Sensing 5
High Readings 5
Connection Problem 4
No Display / Image 4
Device Operational Issue 4
Image Resolution Poor 3
Power Problem 3
Output Problem 3
Material Distortion 3
Failure to Disconnect 2
Malposition of device 2
Difficult to Insert 2
Break 2
Mechanical Problem 2
Noise, Audible 2
Calibration Problem 2
Material Integrity Problem 2
Difficult to Remove 2
Failure to Sense 2
Activation, Positioning or Separation Problem 2
Chemical Problem 2
Intermittent Continuity 2
Patient-Device Incompatibility 1
Bent 1
Human-Device Interface Problem 1
Compatibility Problem 1
No Device Output 1
Premature Activation 1
Incorrect Or Inadequate Test Results 1
Loose or Intermittent Connection 1
Device Damaged Prior to Use 1
Grounding Malfunction 1
Positioning Problem 1
False Device Output 1
Component Incompatible 1
Material Deformation 1
Low pH 1
Total Device Problems 3502

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II May-06-2016

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