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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
gas-machine, anesthesia
Product Code
BSZ
Regulation Number
868.5160
Device Class
2
Premarket Reviews
Manufacturer
Decision
MAQUET CRITICAL CARE AB
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2018
2588
2588
2019
1957
2270
2020
2687
2687
2021
3124
3124
2022
4323
4323
Device Problems
MDRs with this Device Problem
Events in those MDRs
Therapeutic or Diagnostic Output Failure
3925
4120
Mechanical Problem
1903
1931
Output Problem
748
748
Gas/Air Leak
725
757
No Display/Image
700
700
Failure to Run on Battery
610
610
Failure to Deliver
556
556
Increase in Pressure
530
544
Unexpected Shutdown
456
461
Gas Output Problem
434
434
Infusion or Flow Problem
427
437
Appropriate Term/Code Not Available
375
375
Unexpected Therapeutic Results
321
324
Inaccurate Delivery
317
319
Physical Resistance/Sticking
277
282
Break
262
266
Suction Failure
253
257
Decrease in Suction
237
246
Device Alarm System
204
204
Device Operates Differently Than Expected
202
202
Device Displays Incorrect Message
197
197
Pressure Problem
163
167
Inappropriate or Unexpected Reset
153
154
Detachment of Device or Device Component
139
139
Energy Output Problem
138
140
Leak/Splash
121
121
No Audible Alarm
117
118
Intermittent Continuity
111
111
Mechanical Jam
108
108
Suction Problem
86
86
No Pressure
83
83
Intermittent Communication Failure
77
77
Incorrect, Inadequate or Imprecise Result or Readings
69
69
Decrease in Pressure
65
65
No Visual Prompts/Feedback
65
65
Protective Measures Problem
57
57
Tidal Volume Fluctuations
53
53
Insufficient Information
51
51
Defective Device
45
45
Battery Problem
45
45
Excess Flow or Over-Infusion
39
39
No Flow
39
39
High Readings
36
36
Display or Visual Feedback Problem
35
35
Adverse Event Without Identified Device or Use Problem
34
34
Material Integrity Problem
34
34
Computer Software Problem
31
31
Failure to Analyze Signal
31
31
Use of Device Problem
30
30
Crack
25
25
Sticking
23
23
Failure of Device to Self-Test
23
23
Improper Flow or Infusion
23
23
Circuit Failure
22
22
Loose or Intermittent Connection
22
22
Failure to Sense
21
21
Complete Loss of Power
20
20
Loss of Power
19
19
Defective Alarm
19
21
Device Fell
18
18
Contamination /Decontamination Problem
17
17
Device Tipped Over
14
14
Premature Discharge of Battery
13
13
Calibration Problem
12
12
Device Sensing Problem
12
12
Failure to Calibrate
11
11
Noise, Audible
11
11
Activation Failure
10
10
Reset Problem
10
10
Power Problem
10
10
Improper or Incorrect Procedure or Method
10
10
Defective Component
10
10
Device Inoperable
10
10
Electrical /Electronic Property Problem
10
10
Disconnection
9
9
Insufficient Flow or Under Infusion
9
9
Computer System Security Problem
9
9
Ventilation Problem in Device Environment
9
9
No Apparent Adverse Event
8
8
Component Missing
8
8
Device Reprocessing Problem
8
8
Failure to Power Up
8
8
Electrical Overstress
7
7
Data Problem
7
7
Communication or Transmission Problem
6
6
Computer Operating System Problem
6
6
Loss of Threshold
6
6
No Device Output
6
6
Inflation Problem
5
5
Inaccurate Flow Rate
5
5
Fire
5
5
Device Handling Problem
5
5
Misassembly by Users
4
4
Free or Unrestricted Flow
4
4
Moisture or Humidity Problem
4
4
Material Split, Cut or Torn
4
4
Intermittent Loss of Power
4
4
Complete Blockage
4
4
False Alarm
4
4
Fluid/Blood Leak
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7412
7412
No Patient Involvement
4105
4141
No Consequences Or Impact To Patient
1925
1925
Insufficient Information
771
771
No Known Impact Or Consequence To Patient
258
533
Low Oxygen Saturation
70
70
Cardiac Arrest
22
22
Awareness during Anaesthesia
18
18
Death
18
18
Patient Problem/Medical Problem
15
15
No Information
13
13
Hypoxia
8
8
Cyanosis
7
7
No Code Available
5
5
Loss of consciousness
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Vomiting
4
4
Brain Injury
4
4
Tachycardia
4
4
Low Blood Pressure/ Hypotension
4
4
Burn(s)
4
4
Bradycardia
3
3
Cardiopulmonary Arrest
3
3
Hypoventilation
3
7
Therapeutic Effects, Unexpected
3
5
Pneumothorax
3
3
Respiratory Distress
3
3
Nausea
2
2
Oversedation
2
2
Urinary Retention
2
2
Partial thickness (Second Degree) Burn
2
2
Convulsion/Seizure
2
2
Respiratory Arrest
2
2
Metal Related Pathology
1
1
Solid Tumour
1
1
Urinary Incontinence
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Cough
1
1
Premature Labor
1
1
Intraoperative Pain
1
1
Respiratory Acidosis
1
1
Suture Abrasion
1
1
Low Cardiac Output
1
1
Sudden Cardiac Death
1
1
Lethargy
1
1
Blurred Vision
1
1
Pulmonary Edema
1
1
Pulmonary Insufficiency
1
1
Respiratory Distress Syndrome of Newborns
1
1
Swelling
1
1
Cardiac Tamponade
1
1
Injury
1
1
Overinflation of Lung
1
1
Coma
1
1
Failure of Implant
1
1
Dyspnea
1
1
Eye Injury
1
1
Bone Fracture(s)
1
1
Headache
1
1
High Blood Pressure/ Hypertension
1
1
Apnea
1
1
Arrhythmia
1
1
Abrasion
1
1
Airway Obstruction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Draeger Medical, Inc.
II
Jan-14-2022
2
Draeger Medical, Inc.
II
Jun-19-2018
3
Draeger Medical, Inc.
I
May-08-2018
4
GE Healthcare, LLC
II
Jul-20-2022
5
GE Healthcare, LLC
I
Jul-19-2022
6
GE Healthcare, LLC
II
Jun-24-2022
7
GE Healthcare, LLC
II
Sep-30-2021
8
GE Healthcare, LLC
II
Oct-30-2020
9
GE Healthcare, LLC
I
Jan-23-2020
10
GE Healthcare, LLC
II
Dec-17-2019
11
GE Healthcare, LLC
II
Nov-09-2018
12
GE Healthcare, LLC
II
Mar-26-2018
13
GE Medical Systems China Co., Ltd.
II
Aug-30-2018
14
GE Medical Systems China Co., Ltd.
II
Feb-09-2018
15
Getinge Group Logistics America, LLC
II
Mar-05-2021
16
Getinge Usa Sales Inc
I
Jan-26-2023
17
Getinge Usa Sales Inc
II
Dec-07-2022
18
Getinge Usa Sales Inc
I
Jun-23-2022
19
Getinge Usa Sales Inc
I
Jan-10-2022
20
Mindray DS USA, Inc. dba Mindray North America
II
Mar-02-2018
-
-