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 monitor, blood-gas, on-line, cardiopulmonary bypass
Product CodeDRY
Regulation Number 870.4330
Device Class 2


Premarket Reviews
ManufacturerDecision
LIVANOVA DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 63 63
2020 35 35
2021 42 42
2022 37 37
2023 41 41
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 121 121
Leak/Splash 61 61
Smoking 5 5
Thermal Decomposition of Device 5 5
Electrical /Electronic Property Problem 4 4
Failure to Power Up 4 4
Unable to Obtain Readings 3 3
Electrical Overstress 2 2
Incorrect Measurement 2 2
Decrease in Pressure 1 1
High pH 1 1
Failure to Calibrate 1 1
Sparking 1 1
Calibration Problem 1 1
Fluid/Blood Leak 1 1
Gel Leak 1 1
Image Display Error/Artifact 1 1
Degraded 1 1
Disconnection 1 1
Display or Visual Feedback Problem 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Gas/Air Leak 1 1
Inappropriate or Unexpected Reset 1 1
Insufficient Information 1 1
Complete Loss of Power 1 1
Failure to Recalibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 120 120
No Consequences Or Impact To Patient 58 58
No Patient Involvement 32 32
Insufficient Information 10 10
No Known Impact Or Consequence To Patient 6 6
Blood Loss 5 5
No Information 4 4
Death 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Nov-12-2020
-
-