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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bariatric bed
Definition A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.
Product CodeOSI
Regulation Number 880.5100
Device Class 2

MDR Year MDR Reports MDR Events
2014 101 101
2015 124 124
2016 72 72
2017 7 7
2018 16 16
2019 22 22
2020 15 15
2021 30 39
2022 37 51
2023 176 185
2024 51 58

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 135 135
Break 77 77
Bent 46 46
Device Slipped 45 45
Sparking 36 36
Device Operates Differently Than Expected 26 26
Mechanical Problem 26 26
Smoking 24 24
Activation Problem 22 22
Material Frayed 21 21
Unintended Movement 20 20
Unintended System Motion 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Fire 14 14
Incorrect Measurement 12 44
Electrical /Electronic Property Problem 12 12
Appropriate Term/Code Not Available 11 11
Positioning Failure 9 16
Use of Device Problem 9 9
Material Deformation 8 8
Material Protrusion/Extrusion 7 7
Detachment Of Device Component 7 7
No Audible Alarm 7 7
Device Alarm System 7 7
Inflation Problem 7 7
Loose or Intermittent Connection 7 7
Component Falling 6 6
Noise, Audible 6 6
Insufficient Information 6 6
Thermal Decomposition of Device 5 5
Self-Activation or Keying 5 5
Sticking 5 5
Component Missing 4 4
Connection Problem 4 4
Crack 4 4
Unintended Head Motion 4 4
Device Fell 4 4
No Apparent Adverse Event 4 4
Mechanics Altered 3 3
Material Integrity Problem 3 3
Device Emits Odor 3 3
Melted 3 3
Collapse 3 3
Defective Alarm 3 3
Detachment of Device or Device Component 3 3
Electrical Shorting 3 3
Device Inoperable 3 3
Defective Component 3 3
Split 2 2
Arcing 2 2
Malposition of Device 2 2
Device Dislodged or Dislocated 2 2
Out-Of-Box Failure 2 2
Material Separation 2 2
Improper or Incorrect Procedure or Method 2 2
Peeled/Delaminated 2 2
Loss of Power 2 2
Material Fragmentation 2 2
Disconnection 2 2
Human Factors Issue 2 2
Human-Device Interface Problem 2 2
Naturally Worn 2 2
Mechanical Jam 2 2
Torn Material 2 2
Pressure Problem 2 2
Unintended Electrical Shock 2 2
Sharp Edges 1 1
Patient Device Interaction Problem 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Positioning Problem 1 1
Material Twisted/Bent 1 1
Leak/Splash 1 1
Misassembled 1 1
Nonstandard Device 1 1
Overheating of Device 1 1
Low Audible Alarm 1 1
Burst Container or Vessel 1 1
Circuit Failure 1 1
Intermittent Continuity 1 1
Material Discolored 1 1
Entrapment of Device 1 1
Failure to Pump 1 1
Product Quality Problem 1 1
Device Remains Activated 1 1
Device Stops Intermittently 1 1
Inadequate or Insufficient Training 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Malfunction 1 1
Structural Problem 1 1
Failure to Align 1 1
Flare or Flash 1 1
Gas/Air Leak 1 1
Activation, Positioning or Separation Problem 1 1
Device-Device Incompatibility 1 1
Patient-Device Incompatibility 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 235 274
No Known Impact Or Consequence To Patient 205 205
No Information 49 49
Insufficient Information 24 24
No Patient Involvement 23 23
Fall 23 23
No Consequences Or Impact To Patient 22 22
Pressure Sores 12 12
Electric Shock 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Laceration(s) 5 5
Bruise/Contusion 5 5
Unspecified Tissue Injury 5 5
Death 4 4
Pain 4 4
Discomfort 4 4
Injury 4 4
Skin Tears 3 3
Hip Fracture 2 2
Shock 2 2
Physical Entrapment 2 2
Bone Fracture(s) 2 2
Burn(s) 2 2
Cardiac Arrest 1 1
Corneal Edema 1 1
Dyspnea 1 1
Ecchymosis 1 1
Abrasion 1 1
Airway Obstruction 1 1
Erosion 1 1
Hematoma 1 1
Tissue Damage 1 1
Fracture, Arm 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1
Complaint, Ill-Defined 1 1
Weight Changes 1 1
No Code Available 1 1
Localized Skin Lesion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Kreg Medical Inc. II Jun-05-2013
2 SCM True Air Technologies LLC II May-19-2014
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