Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
Mechanics Altered 16 16
Positioning Problem 16 61
Scratched Material 15 15
Failure to Disconnect 13 13
Device Displays Incorrect Message 13 13
Mechanical Jam 13 14
Improper Device Output 13 13
Naturally Worn 11 11
Component Missing 10 10
Failure to Zero 9 9
Unintended System Motion 9 9
Failure to Align 9 9
Insufficient Information 8 8
Malposition of Device 8 8
Device Inoperable 7 7
Patient Device Interaction Problem 6 7
Calibration Problem 6 6
Material Integrity Problem 5 5
Defective Component 5 5
Output Problem 5 5
Material Separation 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Crack 4 4
Material Frayed 4 4
Connection Problem 4 4
Unstable 4 4
Defective Device 3 3
Sharp Edges 3 3
Human-Device Interface Problem 3 3
Incorrect Or Inadequate Test Results 3 3
Disconnection 3 3
Bent 3 3
Delamination 3 3
Difficult To Position 2 2
Detachment of Device or Device Component 2 2
Battery 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
Head Injury 1 1
Bone Fracture(s) 1 1
Cardiac Arrest 1 1
Concussion 1 1
Pain 1 2
Bradycardia 1 1
Vertebral Fracture 1 1
Low Oxygen Saturation 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
-
-