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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device alarm, blood-pressure
Regulation Description Blood pressure alarm.
Product CodeDSJ
Regulation Number 870.1100
Device Class 2

MDR Year MDR Reports MDR Events
2021 32 32
2022 27 27
2023 16 16
2024 30 30
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Prompt/Feedback 29 29
No Audible Alarm 24 24
Detachment of Device or Device Component 18 18
Device Fell 9 9
High Readings 6 6
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Incorrect Measurement 4 4
Application Program Freezes, Becomes Nonfunctional 4 4
Sparking 2 2
Fire 2 2
Break 1 1
Output Problem 1 1
Accessory Incompatible 1 1
Device Alarm System 1 1
Insufficient Information 1 1
Failure to Transmit Record 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Patient Device Interaction Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Data Problem 1 1
Low Readings 1 1
Appropriate Term/Code Not Available 1 1
Display or Visual Feedback Problem 1 1
Inappropriate Audible Prompt/Feedback 1 1
Device Displays Incorrect Message 1 1
Intermittent Loss of Power 1 1
Continuous Firing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 104 104
Numbness 1 1
Insufficient Information 1 1
No Consequences Or Impact To Patient 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips North America Llc II Sep-29-2023
2 Philips North America Llc II May-26-2023
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