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
2019 8 8
2020 4 4
2021 8 8
2022 29 29
2023 12 12
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 18 18
No Display/Image 14 14
Output Problem 9 9
Unintended Movement 8 8
Thermal Decomposition of Device 7 7
Loss of Power 7 7
Intermittent Energy Output 5 5
Positioning Problem 4 4
Ambient Temperature Problem 4 4
Material Discolored 4 4
Overheating of Device 4 4
Device Slipped 2 2
Device Fell 2 2
Energy Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Sparking 1 1
Unstable 1 1
Material Integrity Problem 1 1
Difficult or Delayed Positioning 1 1
Electrical Shorting 1 1
Degraded 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Device Output 1 1
Break 1 1
Failure to Power Up 1 1
Material Twisted/Bent 1 1
Fracture 1 1
Unintended System Motion 1 1
Melted 1 1
Nonstandard Device 1 1
Arcing 1 1
Loose or Intermittent Connection 1 1
Display or Visual Feedback Problem 1 1
Intermittent Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 49 49
Insufficient Information 12 12
No Known Impact Or Consequence To Patient 10 10
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
-
-