• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device cart, emergency, cardiopulmonary (excluding equipment)
Regulation Description Cardiopulmonary emergency cart.
Product CodeBZN
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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 19 19
No Display/Image 14 14
Output Problem 9 9
Positioning Problem 7 7
Thermal Decomposition of Device 7 7
Loss of Power 6 6
Unintended Movement 6 6
Intermittent Energy Output 5 5
Ambient Temperature Problem 4 4
Overheating of Device 4 4
Material Discolored 4 4
Device Slipped 2 2
Energy Output Problem 2 2
Difficult or Delayed Positioning 1 1
Sparking 1 1
Break 1 1
Electrical Shorting 1 1
Unintended System Motion 1 1
Failure to Power Up 1 1
No Device Output 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Intermittent Loss of Power 1 1
Display or Visual Feedback Problem 1 1
Arcing 1 1
Electrical Power Problem 1 1
Fire 1 1
Degraded 1 1
Unstable 1 1
Loose or Intermittent Connection 1 1
Fracture 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 54 54
Insufficient Information 12 12
No Known Impact Or Consequence To Patient 2 2
Laceration(s) 1 1
Cough 1 1
Headache 1 1
No Consequences Or Impact To Patient 1 1
Superficial (First Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Corporation II Mar-05-2020
-
-