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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device gas-machine, anesthesia
Product CodeBSZ
Regulation Number 868.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K171292  A7 Anesthesia System
  2.  K171311  A5 Anesthesia System
  3.  K201957  A8, A9 Anesthesia System

MDR Year MDR Reports MDR Events
2017 2355 2355
2018 2588 2588
2019 1957 2270
2020 2687 2687
2021 3124 3124
2022 3544 3544

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 3775 3970
Mechanical Problem 1784 1812
Device Operates Differently Than Expected 1012 1012
Appropriate Term/Code Not Available 738 738
Output Problem 722 722
Gas/Air Leak 711 743
No Display/Image 615 615
Failure to Deliver 532 532
Increase in Pressure 519 533
Failure to Run on Battery 463 463
Device Alarm System 450 450
Unexpected Shutdown 431 436
Infusion or Flow Problem 428 438
Gas Output Problem 423 423
Device Displays Incorrect Message 366 366
Unexpected Therapeutic Results 313 316
Leak/Splash 308 308
Break 302 306
Inaccurate Delivery 299 301
Physical Resistance/Sticking 269 274
Suction Failure 250 254
Decrease in Suction 231 240
Pressure Problem 221 225
Suction Problem 177 177
Inappropriate or Unexpected Reset 142 143
Energy Output Problem 136 138
Detachment of Device or Device Component 133 133
No Audible Alarm 119 120
Mechanical Jam 108 108
Intermittent Continuity 107 107
Excess Flow or Over-Infusion 100 100
Device Inoperable 94 94
Tidal Volume Fluctuations 85 85
No Pressure 83 83
Intermittent Communication Failure 72 72
Incorrect, Inadequate or Imprecise Result or Readings 69 69
High Readings 66 66
Decrease in Pressure 61 61
Sticking 58 58
Protective Measures Problem 58 58
Loss of Power 56 56
No Visual Prompts/Feedback 52 52
Insufficient Information 50 50
Battery Problem 48 48
Defective Device 45 45
Failure of Device to Self-Test 41 41
No Flow 39 39
Display or Visual Feedback Problem 37 37
Material Integrity Problem 34 34
Computer Software Problem 33 33
Adverse Event Without Identified Device or Use Problem 32 32
Failure to Analyze Signal 31 31
Use of Device Problem 31 31
Crack 28 28
Improper Flow or Infusion 28 28
Defective Alarm 25 27
Failure to Calibrate 25 25
Loose or Intermittent Connection 23 23
Circuit Failure 21 21
Failure to Sense 21 21
Complete Loss of Power 20 20
Device Fell 18 18
Contamination /Decontamination Problem 17 17
Noise, Audible 15 15
Ventilation Problem in Device Environment 15 15
Reset Problem 14 14
Device Tipped Over 14 14
Calibration Problem 13 13
Premature Discharge of Battery 13 13
Improper or Incorrect Procedure or Method 12 12
Power Problem 12 12
Insufficient Flow or Under Infusion 11 11
Computer Operating System Problem 11 11
Failure to Power Up 11 11
Disconnection 10 10
Electrical /Electronic Property Problem 10 10
Device Sensing Problem 10 10
Defective Component 10 10
Component Missing 10 10
Computer System Security Problem 9 9
Activation Failure 9 9
Communication or Transmission Problem 8 8
Device Reprocessing Problem 8 8
Electrical Overstress 7 7
Data Problem 7 7
Device Dislodged or Dislocated 6 6
Loss of Threshold 6 6
No Device Output 6 6
Inaccurate Flow Rate 6 6
Fire 5 5
Inflation Problem 5 5
Unable to Obtain Readings 5 5
Device Handling Problem 5 5
No Apparent Adverse Event 5 5
Intermittent Loss of Power 4 4
Difficult to Open or Close 4 4
Human-Device Interface Problem 4 4
Free or Unrestricted Flow 4 4
Moisture or Humidity Problem 4 4
Self-Activation or Keying 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6647 6647
No Patient Involvement 5624 5660
No Consequences Or Impact To Patient 2626 2626
Insufficient Information 758 758
No Known Impact Or Consequence To Patient 382 657
Low Oxygen Saturation 73 73
No Information 24 24
Cardiac Arrest 23 23
Awareness during Anaesthesia 21 21
Death 20 20
Patient Problem/Medical Problem 15 15
No Code Available 11 11
Hypoxia 9 9
Cyanosis 7 7
Low Blood Pressure/ Hypotension 5 5
Loss of consciousness 5 5
Burn(s) 4 4
Tachycardia 4 4
Brain Injury 4 4
Respiratory Distress 3 3
Vomiting 3 3
Therapeutic Effects, Unexpected 3 5
Pneumothorax 3 3
Bradycardia 3 3
Cardiopulmonary Arrest 3 3
Hypoventilation 3 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Partial thickness (Second Degree) Burn 2 2
Respiratory Arrest 2 2
Injury 2 2
Respiratory Failure 2 2
Oversedation 2 2
Urinary Retention 2 2
Blurred Vision 1 1
Pulmonary Edema 1 1
Pulmonary Insufficiency 1 1
Dizziness 1 1
Respiratory Distress Syndrome of Newborns 1 1
Swelling 1 1
Cardiac Tamponade 1 1
Complaint, Ill-Defined 1 1
Failure of Implant 1 1
Nausea 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
Suture Abrasion 1 1
Low Cardiac Output 1 1
Sudden Cardiac Death 1 1
Sleep Dysfunction 1 1
Lethargy 1 1
Loss Of Pulse 1 1
Overinflation of Lung 1 1
Coma 1 1
Forced Expiratory Volume Decreased 1 1
Premature Labor 1 1
Convulsion/Seizure 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Cough 1 1
Respiratory Acidosis 1 1
Intraoperative Pain 1 1
Metal Related Pathology 1 1
Solid Tumour 1 1
Urinary Incontinence 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Del Mar Reynolds Medical, Ltd. II May-16-2017
2 Draeger Medical, Inc. II Jan-14-2022
3 Draeger Medical, Inc. II Jun-19-2018
4 Draeger Medical, Inc. I May-08-2018
5 GE Healthcare, LLC II Jul-20-2022
6 GE Healthcare, LLC I Jul-19-2022
7 GE Healthcare, LLC II Jun-24-2022
8 GE Healthcare, LLC II Sep-30-2021
9 GE Healthcare, LLC II Oct-30-2020
10 GE Healthcare, LLC I Jan-23-2020
11 GE Healthcare, LLC II Dec-17-2019
12 GE Healthcare, LLC II Nov-09-2018
13 GE Healthcare, LLC II Mar-26-2018
14 GE Healthcare, LLC II May-24-2017
15 GE Medical Systems China Co., Ltd. II Aug-30-2018
16 GE Medical Systems China Co., Ltd. II Feb-09-2018
17 Getinge Group Logistics America, LLC II Mar-05-2021
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
21 Spacelabs Healthcare, Ltd. I Nov-21-2017
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