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TPLC
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show TPLC since
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Device
alarm, blood-pressure
Product Code
DSJ
Regulation Number
870.1100
Device Class
2
Premarket Reviews
Manufacturer
Decision
PHILIPS MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
2
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
SUBSTANTIALLY EQUIVALENT
1
PHILLIPS MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2015
2
2
2017
1
1
2019
2
2
2021
32
32
2022
27
27
2023
16
16
2024
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Audible Prompt/Feedback
26
26
No Audible Alarm
18
18
Detachment of Device or Device Component
17
17
Device Fell
8
8
High Readings
6
6
Incorrect Measurement
4
4
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Device Operates Differently Than Expected
3
3
Sparking
2
2
No Display/Image
2
2
Fire
2
2
Low Readings
1
1
Nonstandard Device
1
1
Intermittent Loss of Power
1
1
Inappropriate Audible Prompt/Feedback
1
1
Display or Visual Feedback Problem
1
1
Device Displays Incorrect Message
1
1
Device Alarm System
1
1
Application Program Problem
1
1
Insufficient Information
1
1
Failure to Transmit Record
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Data Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Break
1
1
Output Problem
1
1
Moisture Damage
1
1
Patient Device Interaction Problem
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Appropriate Term/Code Not Available
1
1
Continuous Firing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
89
89
No Consequences Or Impact To Patient
3
3
No Information
1
1
No Known Impact Or Consequence To Patient
1
1
No Patient Involvement
1
1
Insufficient Information
1
1
Numbness
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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