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
vaporizer, anesthesia, non-heated
Product Code
CAD
Regulation Number
868.5880
Device Class
2
Premarket Reviews
Manufacturer
Decision
DATEX-OHMEDA, INC.
SUBSTANTIALLY EQUIVALENT
1
PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC)
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
41
41
2016
9
9
2017
14
14
2018
10
10
2019
12
14
2020
11
11
2021
12
12
2022
13
13
2023
44
44
2024
35
35
Device Problems
MDRs with this Device Problem
Events in those MDRs
Infusion or Flow Problem
34
36
Insufficient Flow or Under Infusion
28
28
Unexpected Therapeutic Results
19
19
Inaccurate Delivery
14
14
Device Operates Differently Than Expected
13
13
Device Inoperable
13
13
Mechanical Problem
9
9
Appropriate Term/Code Not Available
7
7
Break
6
6
Leak/Splash
5
5
Insufficient Information
4
4
Gas/Air Leak
4
4
Improper Flow or Infusion
3
3
No Flow
3
3
Output Problem
3
3
Gas Output Problem
3
3
Excess Flow or Over-Infusion
3
3
Component Missing
3
3
Failure to Deliver
3
3
High Readings
3
3
Electrical Overstress
2
2
Connection Problem
2
2
Defective Device
2
2
No Display/Image
2
2
Overheating of Device
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Handling Problem
2
2
Activation Failure
1
1
Defective Alarm
1
1
Application Program Problem: Medication Error
1
1
No Apparent Adverse Event
1
1
Mechanical Jam
1
1
Naturally Worn
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Self-Activation or Keying
1
1
Sticking
1
1
Stretched
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Electrical /Electronic Property Problem
1
1
Restricted Flow rate
1
1
Inaccurate Flow Rate
1
1
Fluid/Blood Leak
1
1
Fracture
1
1
Loose or Intermittent Connection
1
1
Chemical Spillage
1
1
Computer Operating System Problem
1
1
Low Test Results
1
1
Detachment of Device or Device Component
1
1
Device Markings/Labelling Problem
1
1
Low Readings
1
1
Failure to Align
1
1
Fumes or Vapors
1
1
Melted
1
1
Device Emits Odor
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
92
92
No Patient Involvement
37
37
No Consequences Or Impact To Patient
23
23
No Known Impact Or Consequence To Patient
20
22
Awareness during Anaesthesia
15
15
No Information
3
3
High Blood Pressure/ Hypertension
3
3
Insufficient Information
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Low Blood Pressure/ Hypotension
2
2
Chemical Exposure
2
2
Abnormal Blood Gases
1
1
Burn(s)
1
1
Cardiac Arrest
1
1
No Code Available
1
1
Convulsion/Seizure
1
1
Syncope/Fainting
1
1
Paresthesia
1
1
Neurological Deficit/Dysfunction
1
1
Pain
1
1
Red Eye(s)
1
1
Burning Sensation
1
1
Dizziness
1
1
Shock, Traumatic
1
1
Inadequate Pain Relief
1
1
Palpitations
1
1
Low Oxygen Saturation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Draeger Medical, Inc.
II
May-25-2016
2
GE Healthcare, LLC
II
Mar-26-2018
3
Penlon, Ltd.
II
Jul-02-2013
-
-