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 accessory to continuous ventilator (respirator)
Product CodeMOD
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
CARDIOPULMONARY CORP.
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 3 3
2016 1 1
2019 6 6
2020 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 4 4
Mechanics Altered 2 2
Collapse 2 2
Crack 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Disconnection 1 1
Failure to Deliver 1 1
Connection Problem 1 1
Improper Device Output 1 1
Physical Property Issue 1 1
Bent 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 7 7
No Patient Involvement 4 4
Wound Dehiscence 1 1
Bradycardia 1 1
Fall 1 1
Unspecified Infection 1 1
Low Oxygen Saturation 1 1

-
-