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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, bed patient
Regulation Description Bed-patient monitor.
Product CodeKMI
Regulation Number 880.2400
Device Class 1

MDR Year MDR Reports MDR Events
2021 14 14
2022 21 21
2023 35 35
2024 69 69
2025 84 84
2026 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 121 121
Break 35 35
Material Separation 17 17
Device Alarm System 15 15
Adverse Event Without Identified Device or Use Problem 8 8
Defective Alarm 7 7
Intermittent Loss of Power 5 5
Delayed Alarm 5 5
Use of Device Problem 3 3
Electrical /Electronic Property Problem 3 3
Device Dislodged or Dislocated 3 3
Material Split, Cut or Torn 3 3
Loose or Intermittent Connection 2 2
Overheating of Device 2 2
Loss of Power 2 2
Smoking 2 2
Battery Problem 2 2
Unstable 2 2
Human-Device Interface Problem 2 2
Power Problem 2 2
Insufficient Device Problem Information 2 2
Patient Device Interaction Problem 2 2
Device Fell 2 2
Excessive Heating 1 1
Malposition of Device 1 1
Component Missing 1 1
Labelling, Instructions for Use or Training Problem 1 1
Disconnection 1 1
Crack 1 1
Premature Discharge of Battery 1 1
Low Audible Alarm 1 1
False Alarm 1 1
Complete Loss of Power 1 1
Appropriate Device Problem Term/Code Not Available 1 1
No Apparent Adverse Event 1 1
Temperature Problem 1 1
Electrical Overstress 1 1
Device Sensing Problem 1 1
Activation, Positioning or Separation Problem 1 1
Biocompatibility 1 1
Patient-Device Incompatibility 1 1
Sensing Intermittently 1 1
Off-Label Use 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 180 180
Insufficient Information 42 42
Fall 25 25
Bone Fracture(s) 8 8
Laceration(s) 7 7
Abrasion 6 6
Head Injury 4 4
Pressure Sore/Ulcer 4 4
Bruise/Contusion 3 3
Skin Tears 3 3
Intracranial Hemorrhage 2 2
Ecchymosis 2 2
Hematoma 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Peeling 1 1
Vomiting 1 1
Foreign Body In Patient 1 1
Hypersensitivity/Allergic reaction 1 1
Anxiety 1 1
Unspecified Gastrointestinal Problem 1 1
Physical Entrapment 1 1
Fluid Discharge 1 1
No Consequences Or Impact To Patient 1 1
Distress 1 1
Localized Skin Lesion 1 1
Discomfort 1 1
Superficial (First Degree) Burn 1 1
Depression 1 1
Blister 1 1
Cardiac Arrest 1 1

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