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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 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
  1.  K171292  A7 Anesthesia System
  2.  K171311  A5 Anesthesia System
  3.  K201957  A8, A9 Anesthesia System

MDR Year MDR Reports MDR Events
2018 2589 2589
2019 1957 2270
2020 2687 2687
2021 3123 3123
2022 4350 4350
2023 5596 5596
2024 479 479

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 4787 4982
Mechanical Problem 2739 2767
Failure to Run on Battery 1692 1692
No Display/Image 1286 1286
Output Problem 967 967
Gas/Air Leak 890 922
Failure to Deliver 758 758
Increase in Pressure 661 675
Unexpected Shutdown 606 611
Gas Output Problem 592 592
Unexpected Therapeutic Results 499 502
Infusion or Flow Problem 487 497
Insufficient Flow or Under Infusion 475 475
Inaccurate Delivery 405 407
Appropriate Term/Code Not Available 376 376
Physical Resistance/Sticking 300 305
Suction Failure 291 295
Break 289 293
Power Problem 264 264
Decrease in Suction 250 259
Electrical /Electronic Property Problem 211 211
Device Displays Incorrect Message 207 207
Device Alarm System 205 205
Device Operates Differently Than Expected 202 202
Pressure Problem 197 201
Inappropriate or Unexpected Reset 182 183
No Visual Prompts/Feedback 163 163
Detachment of Device or Device Component 157 157
Intermittent Continuity 152 152
Energy Output Problem 144 146
No Audible Alarm 139 140
Leak/Splash 137 137
Failure to Power Up 134 134
Mechanical Jam 108 108
Intermittent Communication Failure 105 105
Suction Problem 103 103
Decrease in Pressure 101 101
Insufficient Information 100 100
No Pressure 85 85
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Protective Measures Problem 66 66
Battery Problem 63 63
Adverse Event Without Identified Device or Use Problem 57 57
No Flow 56 56
Complete Loss of Power 55 55
Tidal Volume Fluctuations 54 54
Display or Visual Feedback Problem 51 51
Defective Device 47 47
Use of Device Problem 45 45
Excess Flow or Over-Infusion 44 44
Failure to Analyze Signal 41 41
High Readings 36 36
Failure to Sense 34 34
Material Integrity Problem 34 34
Computer Software Problem 33 33
Circuit Failure 32 32
Improper Flow or Infusion 28 28
Crack 26 26
Failure of Device to Self-Test 24 24
Loss of Power 23 23
Sticking 23 23
Calibration Problem 23 23
Contamination /Decontamination Problem 22 22
Loose or Intermittent Connection 22 22
Defective Alarm 20 22
Device Fell 18 18
Reset Problem 17 17
Premature Discharge of Battery 17 17
Device Sensing Problem 15 15
Device Tipped Over 14 14
Disconnection 14 14
Failure to Calibrate 12 12
Improper or Incorrect Procedure or Method 12 12
Activation Failure 12 12
Intermittent Loss of Power 12 12
Noise, Audible 11 11
No Apparent Adverse Event 11 11
Electrical Overstress 11 11
Defective Component 10 10
Device Inoperable 10 10
Component Missing 9 9
Computer System Security Problem 9 9
Device Reprocessing Problem 9 9
Ventilation Problem in Device Environment 9 9
Device Handling Problem 8 8
Fire 8 8
No Device Output 7 7
Complete Blockage 7 7
Erratic or Intermittent Display 7 7
Data Problem 7 7
Computer Operating System Problem 6 6
Degraded 6 6
Fluid/Blood Leak 6 6
Device-Device Incompatibility 6 6
Communication or Transmission Problem 6 6
Loss of Threshold 6 6
Failure to Reset 6 6
Incorrect Interpretation of Signal 5 5
Chemical Problem 5 5
Inaccurate Flow Rate 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13457 13457
No Patient Involvement 4105 4141
No Consequences Or Impact To Patient 1925 1925
Insufficient Information 803 803
No Known Impact Or Consequence To Patient 258 533
Low Oxygen Saturation 98 98
Cardiac Arrest 25 25
Awareness during Anaesthesia 22 22
Death 18 18
Patient Problem/Medical Problem 15 15
No Information 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Hypoxia 9 9
Cyanosis 8 8
Bradycardia 6 6
Loss of consciousness 6 6
No Code Available 5 5
Low Blood Pressure/ Hypotension 5 5
Brain Injury 5 5
Vomiting 5 5
Pneumothorax 4 4
Tachycardia 4 4
Burn(s) 4 4
Cardiopulmonary Arrest 3 3
Apnea 3 3
Hypoventilation 3 7
Therapeutic Effects, Unexpected 3 5
Oversedation 3 3
Respiratory Distress 3 3
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
Asystole 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 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
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 Medical Systems China Co., Ltd. II Aug-30-2018
15 GE Medical Systems China Co., Ltd. II Feb-09-2018
16 Getinge Group Logistics America, LLC II Mar-05-2021
17 Getinge Usa Sales Inc II Feb-06-2024
18 Getinge Usa Sales Inc I Jan-26-2023
19 Getinge Usa Sales Inc II Dec-07-2022
20 Getinge Usa Sales Inc I Jun-23-2022
21 Getinge Usa Sales Inc I Jan-10-2022
22 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
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