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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 attached only
Definition This fall-prevention alarm/sensor works only when it is attached to a person. It attaches to a person usually by a clip or belt .
Product CodePJP
Regulation Number 880.2400
Device Class 1

MDR Year MDR Reports MDR Events
2018 6 6
2019 6 6
2020 4 4
2021 2 2
2022 4 4
2023 8 8
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 22 22
Break 4 4
Communication or Transmission Problem 3 3
Device Slipped 2 2
Defective Device 1 1
Mechanical Problem 1 1
False Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16 16
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 2 2
No Information 2 2
Fall 2 2

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