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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device table, operating-room, ac-powered
Product CodeFQO
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2017 98 98
2018 104 104
2019 118 118
2020 97 97
2021 102 102
2022 82 82

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 137 137
Detachment of Device or Device Component 40 40
Insufficient Information 39 39
Mechanical Problem 38 38
Improper or Incorrect Procedure or Method 36 36
Use of Device Problem 34 34
Adverse Event Without Identified Device or Use Problem 29 29
Device Operates Differently Than Expected 25 25
Electromagnetic Interference 23 23
Device Tipped Over 22 22
Unintended System Motion 21 21
Break 20 20
Smoking 19 19
Fluid Leak 15 15
Self-Activation or Keying 14 14
Device Fell 12 12
Loose or Intermittent Connection 11 11
Device Emits Odor 10 10
Device Slipped 10 10
Device Inoperable 9 9
Detachment Of Device Component 9 9
Component Falling 9 9
Noise, Audible 9 9
Positioning Problem 9 9
Fire 8 8
Electrical /Electronic Property Problem 7 7
Failure to Read Input Signal 7 7
Sparking 7 7
Protective Measures Problem 6 6
Device Handling Problem 6 6
Physical Resistance/Sticking 6 6
Battery Problem 5 5
Unstable 5 5
Disconnection 5 5
Circuit Failure 4 4
Collapse 4 4
Leak/Splash 4 4
Defective Device 4 4
Communication or Transmission Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Complete Loss of Power 4 4
Mechanical Jam 4 4
Electrical Shorting 4 4
Operating System Becomes Nonfunctional 3 3
Unintended Electrical Shock 3 3
Patient Device Interaction Problem 3 3
Material Split, Cut or Torn 3 3
Key or Button Unresponsive/not Working 3 3
Sharp Edges 3 3
Device Displays Incorrect Message 3 3
Material Fragmentation 3 3
Unintended Collision 3 3
Thermal Decomposition of Device 3 3
Failure to Charge 2 2
Premature Discharge of Battery 2 2
Material Disintegration 2 2
Melted 2 2
Positioning Failure 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 2 2
Connection Problem 2 2
Device Sensing Problem 2 2
Device Dislodged or Dislocated 2 2
Structural Problem 2 2
Material Separation 2 2
Loss of Power 2 2
Device Difficult to Setup or Prepare 2 2
Output Problem 2 2
Fail-Safe Problem 2 2
Inadequate User Interface 2 2
Installation-Related Problem 2 2
Material Twisted/Bent 2 2
Power Problem 2 2
No Flow 1 1
Temperature Problem 1 1
No Apparent Adverse Event 1 1
Human-Device Interface Problem 1 1
Physical Property Issue 1 1
Unexpected Shutdown 1 1
Separation Problem 1 1
Misassembly During Maintenance/Repair 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Failure to Align 1 1
Suction Problem 1 1
Defective Component 1 1
Electrical Overstress 1 1
Device Unsafe to Use in Environment 1 1
Activation, Positioning or SeparationProblem 1 1
Device Damaged by Another Device 1 1
Computer Operating System Problem 1 1
Calibration Problem 1 1
Device Maintenance Issue 1 1
Labelling, Instructions for Use or Training Problem 1 1
Kinked 1 1
Fracture 1 1
Migration or Expulsion of Device 1 1
Moisture Damage 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 179 179
No Clinical Signs, Symptoms or Conditions 148 148
No Consequences Or Impact To Patient 84 84
Injury 36 36
Insufficient Information 30 30
Fall 25 25
Laceration(s) 19 19
No Code Available 16 16
No Information 15 15
Electric Shock 12 12
Bone Fracture(s) 12 12
No Patient Involvement 8 8
Abrasion 7 7
Head Injury 6 6
Pain 6 6
Crushing Injury 5 5
Death 5 5
Unspecified Tissue Injury 4 4
Pressure Sores 3 3
Burn(s) 3 3
Cardiac Arrest 2 2
Hematoma 2 2
Muscle Weakness 2 2
Nausea 2 2
Nerve Damage 2 2
Low Blood Pressure/ Hypotension 2 2
Discomfort 2 2
Skin Tears 2 2
Hyperextension 2 2
Unspecified Musculoskeletal problem 2 2
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Hematuria 1 1
Physical Entrapment 1 1
Edema 1 1
Shock 1 1
Tissue Damage 1 1
Hemorrhage/Bleeding 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Deerfield Imaging, Inc. II Dec-20-2018
2 Deerfield Imaging, Inc. II Mar-28-2018
3 Deerfield Imaging, Inc. II Mar-27-2018
4 Deerfield Imaging, Inc. II Mar-13-2018
5 Getinge Group Logistics America, LLC II Mar-23-2021
6 Maquet Cardiovascular Us Sales, Llc II Oct-20-2020
7 Skytron, Div. The KMW Group, Inc II Jun-30-2022
8 Skytron, Div. The KMW Group, Inc II Jun-15-2021
9 Skytron, Div. The KMW Group, Inc II Mar-25-2020
10 Stryker Communications II Mar-24-2021
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