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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
2020 17 17
2021 14 14
2022 21 21
2023 35 35
2024 69 69
2025 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 79 79
Device Alarm System 20 20
Break 8 8
Defective Alarm 6 6
Delayed Alarm 5 5
Defective Device 4 4
Communication or Transmission Problem 3 3
Insufficient Information 3 3
Unstable 2 2
Smoking 2 2
Defective Component 2 2
Patient Device Interaction Problem 2 2
Battery Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Loss of Power 2 2
Disconnection 1 1
Off-Label Use 1 1
Patient-Device Incompatibility 1 1
Device Fell 1 1
Failure to Sense 1 1
Electrical Overstress 1 1
Use of Device Problem 1 1
Component Missing 1 1
False Alarm 1 1
Labelling, Instructions for Use or Training Problem 1 1
Product Quality Problem 1 1
Material Separation 1 1
Device Sensing Problem 1 1
Computer Software Problem 1 1
Appropriate Term/Code Not Available 1 1
Excessive Heating 1 1
Intermittent Continuity 1 1
Connection Problem 1 1
Overheating of Device 1 1
Premature Discharge of Battery 1 1
Loose or Intermittent Connection 1 1
Intermittent Loss of Power 1 1
No Device Output 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 89 89
Fall 27 27
Insufficient Information 23 23
Bone Fracture(s) 7 7
Head Injury 5 5
No Known Impact Or Consequence To Patient 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Laceration(s) 3 3
Intracranial Hemorrhage 2 2
Skin Tears 2 2
No Consequences Or Impact To Patient 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
Abrasion 1 1
Blood Loss 1 1
Blister 1 1
Localized Skin Lesion 1 1
Cardiac Arrest 1 1
Injury 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Vomiting 1 1
Discomfort 1 1
Depression 1 1
Peeling 1 1
Fluid Discharge 1 1
Anxiety 1 1
Hemorrhage/Bleeding 1 1
Pressure Sores 1 1
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hill-Rom Inc. II Mar-22-2020
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