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TPLC
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Device
cart, emergency, cardiopulmonary (excluding equipment)
Regulation Description
Cardiopulmonary emergency cart.
Product Code
BZN
Regulation Number
868.6175
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
4
4
2021
8
8
2022
29
29
2023
12
12
2024
7
7
2025
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Display/Image
20
20
Mechanical Problem
19
19
Output Problem
9
9
Positioning Problem
7
7
Thermal Decomposition of Device
7
7
Unintended Movement
6
6
Loss of Power
6
6
Intermittent Energy Output
5
5
Material Discolored
4
4
Ambient Temperature Problem
4
4
Overheating of Device
4
4
Electrical Power Problem
3
3
Device Slipped
2
2
Break
2
2
Energy Output Problem
2
2
Unstable
1
1
Sparking
1
1
Fire
1
1
Device Damaged Prior to Use
1
1
Smoking
1
1
Material Integrity Problem
1
1
Degraded
1
1
Failure to Power Up
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Difficult or Delayed Positioning
1
1
Product Quality Problem
1
1
Electrical Shorting
1
1
Fracture
1
1
Melted
1
1
Unintended System Motion
1
1
Connection Problem
1
1
Display or Visual Feedback Problem
1
1
Electrical /Electronic Property Problem
1
1
Loose or Intermittent Connection
1
1
Arcing
1
1
Intermittent Loss of Power
1
1
No Device Output
1
1
Temperature Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
62
62
Insufficient Information
12
12
No Known Impact Or Consequence To Patient
2
2
Superficial (First Degree) Burn
1
1
Laceration(s)
1
1
Cough
1
1
No Consequences Or Impact To Patient
1
1
Headache
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Corporation
II
Mar-05-2020
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