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
gas-machine, anesthesia
Product Code
BSZ
Regulation Number
868.5160
Device Class
2
Premarket Reviews
Manufacturer
Decision
DATEX-OHMEDA, INC.
SUBSTANTIALLY EQUIVALENT
1
DRÄGERWERK AG CO. KGAA
SUBSTANTIALLY EQUIVALENT
1
MAQUET CRITICAL CARE AB
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1957
2270
2020
2687
2687
2021
3123
3123
2022
4350
4350
2023
5596
5596
2024
928
928
Device Problems
MDRs with this Device Problem
Events in those MDRs
Therapeutic or Diagnostic Output Failure
4762
4957
Mechanical Problem
2659
2687
Failure to Run on Battery
1759
1759
No Display/Image
1304
1304
Gas/Air Leak
845
877
Failure to Deliver
758
758
Increase in Pressure
643
657
Output Problem
641
641
Unexpected Shutdown
597
602
Gas Output Problem
591
591
Insufficient Flow or Under Infusion
540
540
Infusion or Flow Problem
474
484
Unexpected Therapeutic Results
464
467
Inaccurate Delivery
392
394
Power Problem
283
283
Physical Resistance/Sticking
273
278
Suction Failure
273
277
Decrease in Suction
249
258
Electrical /Electronic Property Problem
223
223
Break
213
217
Inappropriate or Unexpected Reset
167
168
No Visual Prompts/Feedback
166
166
Intermittent Continuity
154
154
Pressure Problem
152
156
Detachment of Device or Device Component
143
143
Failure to Power Up
142
142
No Audible Alarm
134
135
Intermittent Communication Failure
106
106
Insufficient Information
103
103
Decrease in Pressure
102
102
No Pressure
71
71
Protective Measures Problem
65
65
Complete Loss of Power
57
57
Incorrect, Inadequate or Imprecise Result or Readings
54
54
Energy Output Problem
53
55
Battery Problem
53
53
Adverse Event Without Identified Device or Use Problem
51
51
Leak/Splash
49
49
Display or Visual Feedback Problem
49
49
Use of Device Problem
47
47
Device Displays Incorrect Message
46
46
No Flow
43
43
Failure to Analyze Signal
42
42
Circuit Failure
29
29
Failure to Sense
29
29
Defective Device
28
28
Appropriate Term/Code Not Available
28
28
Material Integrity Problem
27
27
Computer Software Problem
27
27
Improper Flow or Infusion
24
24
Suction Problem
24
24
Contamination /Decontamination Problem
22
22
Crack
21
21
Loose or Intermittent Connection
21
21
Calibration Problem
20
20
Device Fell
18
18
Defective Alarm
16
18
Premature Discharge of Battery
15
15
Reset Problem
15
15
Activation Failure
14
14
Disconnection
14
14
Tidal Volume Fluctuations
14
14
Device Sensing Problem
13
13
Device Alarm System
13
13
Intermittent Loss of Power
12
12
No Apparent Adverse Event
12
12
Electrical Overstress
11
11
Device Tipped Over
10
10
Computer System Security Problem
9
9
Device Reprocessing Problem
9
9
Excess Flow or Over-Infusion
9
9
Loss of Power
9
9
Degraded
8
8
Component Missing
8
8
Improper or Incorrect Procedure or Method
8
8
Data Problem
8
8
Device Handling Problem
7
7
Failure to Calibrate
7
7
Erratic or Intermittent Display
7
7
Complete Blockage
7
7
Fire
6
6
Incorrect Interpretation of Signal
6
6
No Device Output
6
6
Failure to Reset
6
6
Device-Device Incompatibility
6
6
Noise, Audible
6
6
Misassembly by Users
5
5
Failure to Shut Off
5
5
Chemical Problem
5
5
Loss of Threshold
5
5
Defective Component
5
5
Contamination
5
5
Inaccurate Flow Rate
4
4
Fluid/Blood Leak
4
4
Fracture
4
4
Human-Device Interface Problem
4
4
Moisture or Humidity Problem
4
4
Ventilation Problem in Device Environment
4
4
Unauthorized Access to Computer System
3
3
Material Split, Cut or Torn
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
13897
13897
No Patient Involvement
2375
2411
No Consequences Or Impact To Patient
1170
1170
Insufficient Information
806
806
No Known Impact Or Consequence To Patient
205
480
Low Oxygen Saturation
92
92
Cardiac Arrest
23
23
Awareness during Anaesthesia
15
15
Death
14
14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
No Information
7
7
Hypoxia
7
7
Cyanosis
7
7
Loss of consciousness
6
6
Vomiting
5
5
Bradycardia
5
5
Low Blood Pressure/ Hypotension
5
5
Tachycardia
4
4
Therapeutic Effects, Unexpected
3
5
Respiratory Distress
3
3
Oversedation
3
3
Pneumothorax
3
3
Brain Injury
3
3
Apnea
3
3
Cardiopulmonary Arrest
3
3
Unspecified Respiratory Problem
3
3
Convulsion/Seizure
2
2
Cough
2
2
Respiratory Arrest
2
2
Patient Problem/Medical Problem
2
2
Burn(s)
2
2
Hypoventilation
2
6
Nausea
2
2
Coma
2
2
Cardiac Tamponade
1
1
Overinflation of Lung
1
1
Pulmonary Edema
1
1
Pulmonary Insufficiency
1
1
Respiratory Distress Syndrome of Newborns
1
1
Swelling
1
1
Urinary Retention
1
1
Failure of Implant
1
1
Laceration(s)
1
1
Dyspnea
1
1
Emotional Changes
1
1
Eye Injury
1
1
Headache
1
1
High Blood Pressure/ Hypertension
1
1
Arrhythmia
1
1
Airway Obstruction
1
1
Asystole
1
1
No Code Available
1
1
Metal Related Pathology
1
1
Solid Tumour
1
1
Urinary Incontinence
1
1
Respiratory Acidosis
1
1
Low Cardiac Output
1
1
Sudden Cardiac Death
1
1
Electric Shock
1
1
Lethargy
1
1
Bronchospasm
1
1
Partial thickness (Second Degree) Burn
1
1
Intraoperative Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Draeger Medical, Inc.
II
Jan-14-2022
2
Draegerwerk Ag & Co. Kgaa
II
Feb-01-2024
3
GE Healthcare, LLC
II
Jul-20-2022
4
GE Healthcare, LLC
I
Jul-19-2022
5
GE Healthcare, LLC
II
Jun-24-2022
6
GE Healthcare, LLC
II
Sep-30-2021
7
GE Healthcare, LLC
II
Oct-30-2020
8
GE Healthcare, LLC
I
Jan-23-2020
9
GE Healthcare, LLC
II
Dec-17-2019
10
Getinge Group Logistics America, LLC
II
Mar-05-2021
11
Getinge Usa Sales Inc
II
Feb-06-2024
12
Getinge Usa Sales Inc
I
Jan-26-2023
13
Getinge Usa Sales Inc
II
Dec-07-2022
14
Getinge Usa Sales Inc
I
Jun-23-2022
15
Getinge Usa Sales Inc
I
Jan-10-2022
-
-