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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
Unexpected Therapeutic Results
20
20
Inaccurate Delivery
20
20
Device Inoperable
13
13
Device Operates Differently Than Expected
13
13
Mechanical Problem
9
9
Excess Flow or Over-Infusion
9
9
Low Readings
7
7
Appropriate Term/Code Not Available
7
7
Break
6
6
Leak/Splash
5
5
Insufficient Information
4
4
Gas Output Problem
4
4
Gas/Air Leak
4
4
Output Problem
3
3
Failure to Deliver
3
3
High Readings
3
3
Improper Flow or Infusion
3
3
No Flow
3
3
Component Missing
3
3
No Display/Image
2
2
Device Handling Problem
2
2
Fluid/Blood Leak
2
2
Defective Device
2
2
Electrical Overstress
2
2
Overheating of Device
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Connection Problem
2
2
Detachment of Device or Device Component
2
2
Output below Specifications
1
1
Low Test Results
1
1
Improper or Incorrect Procedure or Method
1
1
Electrical /Electronic Property Problem
1
1
Mechanical Jam
1
1
Loose or Intermittent Connection
1
1
Naturally Worn
1
1
Melted
1
1
Fracture
1
1
Defective Alarm
1
1
No Apparent Adverse Event
1
1
Device Emits Odor
1
1
Activation Failure
1
1
Sticking
1
1
Inaccurate Flow Rate
1
1
Chemical Spillage
1
1
Failure to Align
1
1
Use of Device Problem
1
1
Application Program Problem: Medication Error
1
1
Incorrect, Inadequate or Imprecise Result or Readings
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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