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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
Regulation Description Gas machine for anesthesia or analgesia.
Product CodeBSZ
Regulation Number 868.5160
Device Class 2


Premarket Reviews
ManufacturerDecision
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
2016 2135 2135
2017 2355 2355
2018 2588 2588
2019 1957 2270
2020 2686 2686
2021 1996 1996

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 2601 2796
Device Operates Differently Than Expected 1482 1482
Mechanical Problem 1163 1191
Appropriate Term/Code Not Available 1062 1062
Device Alarm System 630 630
Device Displays Incorrect Message 563 563
Output Problem 542 542
Gas Leak 507 539
Leak/Splash 439 439
Infusion or Flow Problem 375 385
Increase in Pressure 373 387
Break 344 348
Failure to Deliver 344 344
Pressure Problem 326 330
Gas Output Problem 268 268
Unexpected Shutdown 259 264
Unexpected Therapeutic Results 242 245
Suction Problem 227 227
Physical Resistance/Sticking 221 226
Inaccurate Delivery 212 214
Device Inoperable 206 206
Suction Failure 171 175
Decrease in Suction 165 174
Tidal Volume Fluctuations 144 144
Energy Output Problem 133 135
Excess Flow or Over-Infusion 119 119
No Display/Image 110 110
Mechanical Jam 110 110
Inappropriate or Unexpected Reset 105 106
Detachment of Device or Device Component 90 90
Sticking 81 81
No Pressure 80 80
Loss of Power 78 78
No Audible Alarm 69 70
Intermittent Continuity 68 68
Incorrect, Inadequate or Imprecise Resultor Readings 67 67
High Readings 66 66
Failure of Device to Self-Test 55 55
Decrease in Pressure 48 48
Intermittent Communication Failure 45 45
Protective Measures Problem 44 44
No Flow 43 43
Defective Device 43 43
Battery Problem 39 39
Material Integrity Problem 33 33
Insufficient Information 30 30
Improper Flow or Infusion 29 29
Crack 28 28
Failure to Run on Battery 26 26
Loose or Intermittent Connection 25 25
Failure to Calibrate 25 25
Computer Software Problem 24 24
Defective Alarm 24 26
Display or Visual Feedback Problem 23 23
Reset Problem 21 21
Adverse Event Without Identified Device or Use Problem 20 20
Ventilation Problem in Device Environment 18 18
Device Stops Intermittently 18 18
Computer Operating System Problem 18 18
Use of Device Problem 16 16
Air Leak 16 16
Failure to Analyze Signal 16 16
Device Fell 15 15
Failure to Sense 15 15
Noise, Audible 15 15
Device Tipped Over 14 14
Power Problem 14 14
Circuit Failure 13 13
Electrical /Electronic Property Problem 13 13
Failure to Power Up 13 13
Data Problem 12 12
Improper or Incorrect Procedure or Method 11 11
Defective Component 11 11
Calibration Problem 11 11
Communication or Transmission Problem 10 10
Component Missing 10 10
Device Sensing Problem 10 10
Insufficient Flow or Under Infusion 8 8
Complete Loss of Power 8 8
Improper Device Output 8 8
Computer System Security Problem 8 8
Inflation Problem 7 7
Premature Discharge of Battery 7 7
Alarm Not Visible 6 6
Inaccurate Flow Rate 6 6
Detachment Of Device Component 6 6
Unable to Obtain Readings 6 6
Self-Activation or Keying 6 6
Device Damaged Prior to Use 6 6
Device Dislodged or Dislocated 6 6
Electrical Overstress 5 5
Fire 5 5
Incorrect Measurement 5 5
Difficult to Open or Close 5 5
Loss of Threshold 5 5
Disconnection 5 5
Partial Blockage 5 5
Connection Problem 5 5
False Alarm 4 4
Device Handling Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 7056 7092
No Consequences Or Impact To Patient 3182 3182
No Clinical Signs, Symptoms or Conditions 2285 2285
No Known Impact Or Consequence To Patient 525 800
Insufficient Information 512 512
Low Oxygen Saturation 56 56
No Information 27 27
Death 27 27
Awareness during Anaesthesia 24 24
Patient Problem/Medical Problem 16 16
Cardiac Arrest 14 14
No Code Available 13 13
Hypoxia 10 10
Cyanosis 6 6
Burn(s) 4 4
Hypoventilation 4 8
Therapeutic Effects, Unexpected 4 6
Pneumothorax 4 4
Brain Injury 4 4
Respiratory Distress 3 3
Low Blood Pressure/ Hypotension 3 3
Cardiopulmonary Arrest 3 3
High Blood Pressure/ Hypertension 2 2
Oversedation 2 2
Respiratory Failure 2 2
Coma 2 2
Partial thickness (Second Degree) Burn 2 2
Urinary Retention 2 2
Injury 2 2
Bradycardia 2 2
Apnea 1 1
Eye Injury 1 1
Bone Fracture(s) 1 1
Pulmonary Edema 1 1
Pulmonary Insufficiency 1 1
Reaction 1 1
Forced Expiratory Volume Decreased 1 1
Premature Labor 1 1
Suture Abrasion 1 1
Loss Of Pulse 1 1
Blurred Vision 1 1
Dizziness 1 1
Respiratory Distress Syndrome of Newborns 1 1
Tachycardia 1 1
Complaint, Ill-Defined 1 1
Intraoperative Pain 1 1
Respiratory Arrest 1 1
Test Result 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Metal Related Pathology 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Loss of consciousness 1 1
Cardiac Tamponade 1 1
Sudden Cardiac Death 1 1
Sleep Dysfunction 1 1
Swelling 1 1
Abrasion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Aug-30-2016
2 Del Mar Reynolds Medical, Ltd. II May-16-2017
3 Draeger Medical, Inc. II Jun-19-2018
4 Draeger Medical, Inc. I May-08-2018
5 GE Healthcare, LLC II Oct-30-2020
6 GE Healthcare, LLC I Jan-23-2020
7 GE Healthcare, LLC II Dec-17-2019
8 GE Healthcare, LLC II Nov-09-2018
9 GE Healthcare, LLC II Mar-26-2018
10 GE Healthcare, LLC II May-24-2017
11 GE Healthcare, LLC II Dec-14-2016
12 GE Medical Systems China Co., Ltd. II Aug-30-2018
13 GE Medical Systems China Co., Ltd. II Feb-09-2018
14 GE Medical Systems, LLC II Apr-22-2016
15 GE Medical Systems, LLC II Apr-13-2016
16 GE Medical Systems, LLC II Jan-21-2016
17 Getinge Group Logistics America, LLC II Mar-05-2021
18 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
19 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
20 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
21 Spacelabs Healthcare, Ltd. I Nov-21-2017
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