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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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 102 102
Break 26 26
Device Alarm System 17 17
Material Separation 16 16
Adverse Event Without Identified Device or Use Problem 8 8
Defective Alarm 8 8
Intermittent Loss of Power 5 5
Delayed Alarm 5 5
Material Split, Cut or Torn 4 4
Defective Device 3 3
Unstable 2 2
Loss of Power 2 2
Overheating of Device 2 2
Smoking 2 2
Defective Component 2 2
Patient Device Interaction Problem 2 2
Battery Problem 2 2
Use of Device Problem 2 2
Excessive Heating 2 2
Biocompatibility 1 1
No Device Output 1 1
Loose or Intermittent Connection 1 1
Electrical /Electronic Property Problem 1 1
Premature Discharge of Battery 1 1
Connection Problem 1 1
Melted 1 1
Intermittent Continuity 1 1
Appropriate Term/Code Not Available 1 1
Device Sensing Problem 1 1
Detachment of Device or Device Component 1 1
Product Quality Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
False Alarm 1 1
Component Missing 1 1
Therapeutic or Diagnostic Output Failure 1 1
Electrical Overstress 1 1
Failure to Sense 1 1
Device Fell 1 1
Insufficient Information 1 1
Patient-Device Incompatibility 1 1
Crack 1 1
Physical Resistance/Sticking 1 1
Sensing Intermittently 1 1
Off-Label Use 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 142 142
Insufficient Information 31 31
Fall 23 23
Bone Fracture(s) 8 8
Laceration(s) 7 7
Pressure Sores 4 4
Head Injury 3 3
Abrasion 3 3
Skin Tears 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Intracranial Hemorrhage 2 2
Bruise/Contusion 2 2
Superficial (First Degree) Burn 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Gastrointestinal Problem 1 1
Hematoma 1 1
Blister 1 1
Localized Skin Lesion 1 1
Cardiac Arrest 1 1
Foreign Body In Patient 1 1
Vomiting 1 1
Discomfort 1 1
Depression 1 1
Peeling 1 1
Fluid Discharge 1 1
Physical Entrapment 1 1
Anxiety 1 1
No Consequences Or Impact To Patient 1 1
Distress 1 1

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