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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bed, pediatric open hospital
Product CodeFMS
Regulation Number 880.5140
Device Class 2

MDR Year MDR Reports MDR Events
2014 157 157
2015 175 175
2016 137 137
2017 121 121
2018 113 113
2019 30 103
2020 28 139
2021 28 91
2022 22 91
2023 29 130
2024 22 86

Device Problems MDRs with this Device Problem Events in those MDRs
Break 194 194
Device Slipped 170 170
Device Operates Differently Than Expected 117 117
Positioning Failure 52 377
Mechanical Problem 51 51
Sticking 45 45
Device Fell 38 98
False Reading From Device Non-Compliance 30 30
Incorrect Measurement 28 75
Detachment Of Device Component 25 25
Loose or Intermittent Connection 23 23
Component Falling 22 22
Incorrect, Inadequate or Imprecise Result or Readings 17 17
Unintended Movement 17 17
Positioning Problem 16 61
Mechanics Altered 16 16
Scratched Material 15 15
Failure to Disconnect 13 13
Mechanical Jam 13 14
Device Displays Incorrect Message 13 13
Improper Device Output 13 13
Naturally Worn 11 11
Component Missing 10 10
Failure to Align 9 9
Failure to Zero 9 9
Unintended System Motion 9 9
Malposition of Device 8 8
Insufficient Information 8 8
Device Inoperable 7 7
Calibration Problem 6 6
Patient Device Interaction Problem 6 7
Output Problem 5 5
Defective Component 5 5
Material Integrity Problem 5 5
Material Frayed 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Crack 4 4
Unstable 4 4
Connection Problem 4 4
Material Separation 4 4
Disconnection 3 3
Human-Device Interface Problem 3 3
Incorrect Or Inadequate Test Results 3 3
Sharp Edges 3 3
Delamination 3 3
Bent 3 3
Defective Device 3 3
Device Dislodged or Dislocated 2 4
Failure to Calibrate 2 2
Protective Measures Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 534 534
No Consequences Or Impact To Patient 138 138
No Clinical Signs, Symptoms or Conditions 101 423
No Patient Involvement 52 220
Physical Entrapment 10 11
Fall 8 8
Insufficient Information 6 6
Injury 5 5
No Information 4 4
Bruise/Contusion 4 4
Swelling 3 3
Abrasion 2 3
Laceration(s) 2 2
Cyanosis 1 1
Respiratory Arrest 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Cardiac Arrest 1 1
Concussion 1 1
Pain 1 2
Bradycardia 1 1
Low Oxygen Saturation 1 1
Vertebral Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 PediaLift LLC II Feb-02-2020
2 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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