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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


Premarket Reviews
ManufacturerDecision
MOON SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 104 104
2019 118 118
2020 97 97
2021 102 102
2022 125 125
2023 151 151

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 154 154
Use of Device Problem 71 71
Detachment of Device or Device Component 52 52
Insufficient Information 49 49
Mechanical Problem 34 34
Improper or Incorrect Procedure or Method 33 33
Adverse Event Without Identified Device or Use Problem 27 27
Smoking 24 24
Electromagnetic Interference 23 23
Device Tipped Over 22 22
Positioning Problem 22 22
Unintended System Motion 21 21
Positioning Failure 21 21
Device Fell 20 20
Break 18 18
Communication or Transmission Problem 15 15
Device Sensing Problem 14 14
Fluid/Blood Leak 14 14
Battery Problem 11 11
Device Slipped 10 10
Self-Activation or Keying 9 9
Device Emits Odor 9 9
Loose or Intermittent Connection 9 9
Fire 8 8
Device Handling Problem 8 8
Noise, Audible 8 8
Complete Loss of Power 7 7
Sharp Edges 7 7
Electrical /Electronic Property Problem 7 7
Circuit Failure 7 7
Difficult or Delayed Positioning 7 7
Sparking 7 7
Disconnection 6 6
Key or Button Unresponsive/not Working 6 6
Physical Resistance/Sticking 6 6
Electrical Shorting 6 6
Charging Problem 5 5
Device Operates Differently Than Expected 5 5
Therapeutic or Diagnostic Output Failure 5 5
Fracture 5 5
Component Falling 5 5
Defective Device 5 5
Unintended Collision 5 5
Failure to Read Input Signal 5 5
Moisture Damage 4 4
Unstable 4 4
Patient Device Interaction Problem 4 4
No Apparent Adverse Event 4 4
Protective Measures Problem 4 4
Mechanical Jam 4 4
Power Problem 3 3
Operating System Becomes Nonfunctional 3 3
Output Problem 3 3
Material Split, Cut or Torn 3 3
Unintended Electrical Shock 3 3
Device Inoperable 3 3
Leak/Splash 3 3
Collapse 3 3
Detachment Of Device Component 3 3
Material Fragmentation 3 3
Material Disintegration 2 2
Thermal Decomposition of Device 2 2
Failure to Charge 2 2
Premature Discharge of Battery 2 2
Degraded 2 2
Crack 2 2
Loss of Power 2 2
Device Difficult to Setup or Prepare 2 2
Overheating of Device 2 2
Structural Problem 2 2
Patient-Device Incompatibility 2 2
Device Displays Incorrect Message 2 2
Intermittent Communication Failure 2 2
Connection Problem 2 2
Material Twisted/Bent 2 2
Inadequate User Interface 2 2
Installation-Related Problem 2 2
Fail-Safe Problem 2 2
Device Dislodged or Dislocated 2 2
Electrical Overstress 2 2
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Activation, Positioning or Separation Problem 1 1
Computer Operating System Problem 1 1
Device Damaged by Another Device 1 1
Device Unsafe to Use in Environment 1 1
Temperature Problem 1 1
Physical Property Issue 1 1
Naturally Worn 1 1
No Flow 1 1
Separation Problem 1 1
Misassembly During Maintenance/Repair 1 1
Unexpected Shutdown 1 1
Malposition of Device 1 1
Calibration Problem 1 1
Suction Problem 1 1
Defective Component 1 1
Peeled/Delaminated 1 1
Failure to Sense 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 299 299
No Known Impact Or Consequence To Patient 123 123
No Consequences Or Impact To Patient 64 64
Insufficient Information 44 44
Injury 32 32
Fall 27 27
Laceration(s) 27 27
Bone Fracture(s) 17 17
Electric Shock 12 12
No Information 12 12
No Code Available 10 10
Abrasion 8 8
Pain 7 7
No Patient Involvement 7 7
Head Injury 6 6
Unspecified Tissue Injury 6 6
Crushing Injury 5 5
Death 5 5
Burn(s) 4 4
Limb Fracture 4 4
Pressure Sores 3 3
Bruise/Contusion 3 3
Cardiac Arrest 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
Multiple Fractures 2 2
Hyperextension 2 2
Unspecified Musculoskeletal problem 2 2
Localized Skin Lesion 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
Tissue Damage 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 Getinge Usa Sales Inc II Oct-04-2023
7 Getinge Usa Sales Inc II Nov-15-2022
8 IHB OPERATIONS B.V. II Dec-01-2023
9 Maquet Cardiovascular Us Sales, Llc II Oct-20-2020
10 Skytron, Div. The KMW Group, Inc II Jun-30-2022
11 Skytron, Div. The KMW Group, Inc II Jun-15-2021
12 Skytron, Div. The KMW Group, Inc II Mar-25-2020
13 Stryker Communications II Mar-24-2021
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