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TPLC
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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
3
MDR Year
MDR Reports
MDR Events
2018
2589
2589
2019
1957
2270
2020
2687
2687
2021
3123
3123
2022
4350
4350
2023
4486
4486
Device Problems
MDRs with this Device Problem
Events in those MDRs
Therapeutic or Diagnostic Output Failure
4606
4801
Mechanical Problem
2574
2602
Failure to Run on Battery
1468
1468
No Display/Image
1171
1171
Output Problem
912
912
Gas/Air Leak
845
877
Failure to Deliver
706
706
Increase in Pressure
627
641
Unexpected Shutdown
565
570
Gas Output Problem
538
538
Infusion or Flow Problem
468
478
Unexpected Therapeutic Results
422
425
Inaccurate Delivery
393
395
Appropriate Term/Code Not Available
376
376
Physical Resistance/Sticking
295
300
Suction Failure
291
295
Break
288
292
Insufficient Flow or Under Infusion
255
255
Decrease in Suction
250
259
Device Displays Incorrect Message
207
207
Device Alarm System
205
205
Device Operates Differently Than Expected
202
202
Pressure Problem
181
185
Inappropriate or Unexpected Reset
180
181
Electrical /Electronic Property Problem
160
160
Detachment of Device or Device Component
156
156
Power Problem
150
150
No Visual Prompts/Feedback
149
149
Energy Output Problem
141
143
No Audible Alarm
139
140
Intermittent Continuity
138
138
Leak/Splash
126
126
Mechanical Jam
108
108
Suction Problem
103
103
Intermittent Communication Failure
92
92
No Pressure
84
84
Decrease in Pressure
83
83
Failure to Power Up
76
76
Incorrect, Inadequate or Imprecise Result or Readings
69
69
Insufficient Information
69
69
Protective Measures Problem
66
66
Battery Problem
55
55
Tidal Volume Fluctuations
53
53
No Flow
51
51
Adverse Event Without Identified Device or Use Problem
50
50
Defective Device
47
47
Complete Loss of Power
43
43
Excess Flow or Over-Infusion
41
41
Display or Visual Feedback Problem
41
41
Use of Device Problem
40
40
Failure to Analyze Signal
38
38
High Readings
36
36
Material Integrity Problem
34
34
Computer Software Problem
32
32
Circuit Failure
29
29
Failure to Sense
27
27
Crack
26
26
Improper Flow or Infusion
26
26
Failure of Device to Self-Test
24
24
Sticking
23
23
Calibration Problem
22
22
Loose or Intermittent Connection
22
22
Loss of Power
20
20
Defective Alarm
20
22
Contamination /Decontamination Problem
19
19
Device Fell
18
18
Premature Discharge of Battery
16
16
Device Sensing Problem
15
15
Disconnection
14
14
Device Tipped Over
14
14
Failure to Calibrate
12
12
Improper or Incorrect Procedure or Method
12
12
Reset Problem
12
12
Activation Failure
11
11
Noise, Audible
11
11
Electrical Overstress
11
11
Device Inoperable
10
10
Defective Component
10
10
No Apparent Adverse Event
10
10
Intermittent Loss of Power
10
10
Ventilation Problem in Device Environment
9
9
Component Missing
9
9
Computer System Security Problem
9
9
Device Reprocessing Problem
9
9
Complete Blockage
7
7
No Device Output
7
7
Fire
7
7
Data Problem
7
7
Device-Device Incompatibility
6
6
Computer Operating System Problem
6
6
Fluid/Blood Leak
6
6
Communication or Transmission Problem
6
6
Loss of Threshold
6
6
Failure to Reset
5
5
Chemical Problem
5
5
Inaccurate Flow Rate
5
5
Inflation Problem
5
5
Device Handling Problem
5
5
Misassembly by Users
5
5
Material Split, Cut or Torn
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
11885
11885
No Patient Involvement
4105
4141
No Consequences Or Impact To Patient
1925
1925
Insufficient Information
795
795
No Known Impact Or Consequence To Patient
258
533
Low Oxygen Saturation
90
90
Cardiac Arrest
24
24
Awareness during Anaesthesia
22
22
Death
18
18
Patient Problem/Medical Problem
15
15
No Information
13
13
Hypoxia
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Cyanosis
7
7
Bradycardia
6
6
Loss of consciousness
6
6
No Code Available
5
5
Low Blood Pressure/ Hypotension
5
5
Burn(s)
4
4
Pneumothorax
4
4
Tachycardia
4
4
Brain Injury
4
4
Vomiting
4
4
Oversedation
3
3
Respiratory Distress
3
3
Therapeutic Effects, Unexpected
3
5
Cardiopulmonary Arrest
3
3
Apnea
3
3
Hypoventilation
3
7
Unspecified Respiratory Problem
3
3
Convulsion/Seizure
2
2
Cough
2
2
Respiratory Arrest
2
2
Coma
2
2
Partial thickness (Second Degree) Burn
2
2
Urinary Retention
2
2
Nausea
2
2
Pulmonary Edema
1
1
Pulmonary Insufficiency
1
1
Blurred Vision
1
1
Respiratory Distress Syndrome of Newborns
1
1
Swelling
1
1
Cardiac Tamponade
1
1
Injury
1
1
Overinflation of Lung
1
1
Failure of Implant
1
1
Laceration(s)
1
1
Dyspnea
1
1
Emotional Changes
1
1
Eye Injury
1
1
Bone Fracture(s)
1
1
Headache
1
1
High Blood Pressure/ Hypertension
1
1
Arrhythmia
1
1
Abrasion
1
1
Airway Obstruction
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
Electric Shock
1
1
Lethargy
1
1
Bronchospasm
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Metal Related Pathology
1
1
Solid Tumour
1
1
Urinary Incontinence
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
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