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TPLC
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show TPLC since
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2024
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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
91
91
Device Problems
MDRs with this Device Problem
Events in those MDRs
Infusion or Flow Problem
54
56
Insufficient Flow or Under Infusion
42
42
Inaccurate Delivery
20
20
Unexpected Therapeutic Results
20
20
Device Operates Differently Than Expected
13
13
Device Inoperable
13
13
Mechanical Problem
9
9
Excess Flow or Over-Infusion
9
9
Appropriate Term/Code Not Available
7
7
Low Readings
7
7
Break
6
6
Leak/Splash
5
5
Insufficient Information
4
4
Gas/Air Leak
4
4
Gas Output Problem
4
4
Output Problem
3
3
Component Missing
3
3
Improper Flow or Infusion
3
3
Failure to Deliver
3
3
High Readings
3
3
No Flow
3
3
No Display/Image
2
2
Electrical Overstress
2
2
Defective Device
2
2
Fluid/Blood Leak
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Handling Problem
2
2
Detachment of Device or Device Component
2
2
Connection Problem
2
2
Overheating of Device
2
2
Low Test Results
1
1
Output below Specifications
1
1
Defective Alarm
1
1
Fracture
1
1
Stretched
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Fumes or Vapors
1
1
Electrical /Electronic Property Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Mechanical Jam
1
1
Loose or Intermittent Connection
1
1
Self-Activation or Keying
1
1
Naturally Worn
1
1
Melted
1
1
Device Emits Odor
1
1
No Apparent Adverse Event
1
1
Sticking
1
1
Activation Failure
1
1
Computer Operating System Problem
1
1
Inaccurate Flow Rate
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
148
148
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
Insufficient Information
4
4
High Blood Pressure/ Hypertension
3
3
No Information
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Chemical Exposure
2
2
Low Blood Pressure/ Hypotension
2
2
Syncope/Fainting
1
1
Red Eye(s)
1
1
No Code Available
1
1
Abnormal Blood Gases
1
1
Dizziness
1
1
Neurological Deficit/Dysfunction
1
1
Palpitations
1
1
Cardiac Arrest
1
1
Paresthesia
1
1
Burning Sensation
1
1
Burn(s)
1
1
Pain
1
1
Shock, Traumatic
1
1
Convulsion/Seizure
1
1
Inadequate Pain Relief
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
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