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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
2017 121 121
2018 113 113
2019 30 103
2020 28 139
2021 29 92
2022 16 53

Device Problems MDRs with this Device Problem Events in those MDRs
Break 53 53
Device Operates Differently Than Expected 44 44
Device Slipped 35 35
Positioning Failure 31 199
Device Fell 28 67
Mechanical Problem 22 22
Loose or Intermittent Connection 19 19
Incorrect Measurement 15 44
Unintended Movement 14 14
Positioning Problem 13 58
False Reading From Device Non-Compliance 10 10
Incorrect, Inadequate or Imprecise Resultor Readings 10 10
Device Displays Incorrect Message 9 9
Component Falling 7 7
Mechanics Altered 6 6
Patient Device Interaction Problem 5 6
Mechanical Jam 5 6
Failure to Align 5 5
Failure to Zero 5 5
Detachment Of Device Component 5 5
Device Inoperable 5 5
Defective Component 4 4
Component Missing 4 4
Output Problem 4 4
Insufficient Information 4 4
Improper Device Output 3 3
Naturally Worn 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Dislodged or Dislocated 2 4
Connection Problem 2 2
Sharp Edges 2 2
Sticking 2 2
Structural Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Device Tipped Over 1 1
Calibration Problem 1 1
Unstable 1 1
Failure to Calibrate 1 1
Incorrect Or Inadequate Test Results 1 1
High Readings 1 1
Low Readings 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Disconnection 1 1
Entrapment of Device 1 1
Collapse 1 1
Signal Artifact/Noise 1 1
Bent 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Unintended System Motion 1 1
Imprecision 1 1
Physical Resistance/Sticking 1 1
Detachment of Device or Device Component 1 1
Fail-Safe Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 168 168
No Clinical Signs, Symptoms or Conditions 53 178
No Consequences Or Impact To Patient 51 51
No Patient Involvement 48 216
Injury 4 4
Fall 4 4
Swelling 3 3
Physical Entrapment 3 4
No Information 3 3
Abrasion 2 3
Bruise/Contusion 1 1
Concussion 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Pain 1 2

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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