Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
accessory to continuous ventilator (respirator)
Product Code
MOD
Regulation Number
868.5895
Device Class
2
Premarket Reviews
Manufacturer
Decision
CARDIOPULMONARY CORP.
SUBSTANTIALLY EQUIVALENT
1
1. K091461
BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGA
...
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
-
-