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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fall prevention alarm/sensor combination attached or unattached
Regulation Description Bed-patient monitor.
Definition The fall-prevention alarm/sensor is a combination device that can attach to a person usually by a clip or belt OR it can be used unattached to the person, where the person sits upon it.
Product CodePJO
Regulation Number 880.2400
Device Class 1

MDR Year MDR Reports MDR Events
2020 46 46
2021 29 29
2022 20 20
2023 20 20
2024 16 16
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 50 50
Communication or Transmission Problem 32 32
Fail-Safe Problem 22 22
No Audible Prompt/Feedback 6 6
Device Alarm System 4 4
Delayed Alarm 3 3
Insufficient Information 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Appropriate Term/Code Not Available 2 2
Loose or Intermittent Connection 2 2
Disconnection 1 1
Device Slipped 1 1
Break 1 1
Activation Problem 1 1
No Fail-Safe Mechanism 1 1
Key or Button Unresponsive/not Working 1 1
Failure to Power Up 1 1
False Alarm 1 1
Defective Alarm 1 1
Low Audible Alarm 1 1
Complete Loss of Power 1 1
Loss of Power 1 1
Inappropriate Audible Prompt/Feedback 1 1
Intermittent Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 60 60
No Consequences Or Impact To Patient 50 50
Fall 7 7
Insufficient Information 5 5
Bone Fracture(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Known Impact Or Consequence To Patient 1 1
Intracranial Hemorrhage 1 1
Injury 1 1
Foreign Body In Patient 1 1
Laceration(s) 1 1
Limb Fracture 1 1
Bruise/Contusion 1 1

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