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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
Regulation Description Bed-patient monitor.
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
2021 2 2
2022 4 4
2023 8 8
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 14 14
Break 2 2
False Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17

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