Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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)
Product CodeBZN
Regulation Number 868.6175
Device Class 1

MDR Year MDR Reports MDR Events
2018 3 3
2019 8 8
2020 4 4
2021 8 8
2022 29 29
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 14 14
No Display/Image 10 10
Output Problem 8 8
Unintended Movement 8 8
Loss of Power 7 7
Thermal Decomposition of Device 7 7
Intermittent Energy Output 5 5
Overheating of Device 4 4
Ambient Temperature Problem 4 4
Material Discolored 4 4
Positioning Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Material Integrity Problem 2 2
Device Fell 2 2
Energy Output Problem 2 2
Device Slipped 2 2
Unstable 1 1
Arcing 1 1
Sparking 1 1
Break 1 1
Display or Visual Feedback Problem 1 1
Fracture 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Misassembled 1 1
Nonstandard Device 1 1
Unintended System Motion 1 1
Intermittent Loss of Power 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Electrical Shorting 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
Insufficient Information 12 12
No Known Impact Or Consequence To Patient 11 11
No Information 2 2
Laceration(s) 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
-
-