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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 12 61

Device Problems MDRs with this Device Problem Events in those MDRs
Break 194 194
Device Slipped 169 169
Device Operates Differently Than Expected 117 117
Mechanical Problem 50 50
Positioning Failure 49 366
Sticking 45 45
Device Fell 37 92
False Reading From Device Non-Compliance 30 30
Incorrect Measurement 27 72
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
Improper Device Output 13 13
Failure to Disconnect 13 13
Device Displays Incorrect Message 13 13
Naturally Worn 11 11
Mechanical Jam 11 12
Component Missing 10 10
Failure to Align 9 9
Unintended System Motion 9 9
Failure to Zero 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
Defective Component 5 5
Material Integrity Problem 5 5
Output Problem 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Connection Problem 4 4
Material Separation 4 4
Unstable 4 4
Crack 4 4
Material Frayed 4 4
Disconnection 3 3
Bent 3 3
Incorrect Or Inadequate Test Results 3 3
Defective Device 3 3
Delamination 3 3
Human-Device Interface Problem 3 3
Sharp Edges 3 3
Protective Measures Problem 2 2
Detachment of Device or Device Component 2 2
Device Dislodged or Dislocated 2 4
Battery Problem 2 2
Structural Problem 2 2
Failure to Calibrate 2 2
Collapse 2 2
Peeled/Delaminated 2 2
Difficult To Position 2 2
Product Quality Problem 1 1
Failure to Recalibrate 1 1
Misconnection 1 1
Use of Device Problem 1 1
Metal Shedding Debris 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Signal Artifact/Noise 1 1
Difficult or Delayed Positioning 1 1
Entrapment of Device 1 1
False Device Output 1 1
Imprecision 1 1
Fluid/Blood Leak 1 2
Cut In Material 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
High Readings 1 1
Low Readings 1 1
Computer Operating System Problem 1 1
Device Tipped Over 1 1
Low Battery 1 1
Fail-Safe Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Difficult to Open or Close 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Activation, Positioning or Separation Problem 1 1
Measurement System Incompatibility 1 1
Torn Material 1 1
Physical Resistance/Sticking 1 1
Appropriate Term/Code Not Available 1 1

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 92 399
No Patient Involvement 52 220
Physical Entrapment 9 10
Fall 8 8
Insufficient Information 6 6
Injury 5 5
No Information 4 4
Bruise/Contusion 4 4
Swelling 3 3
Laceration(s) 2 2
Abrasion 2 3
Bone Fracture(s) 1 1
Head Injury 1 1
Pain 1 2
Concussion 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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