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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
  1.  K170872  Aisys CS2
  2.  K172045  Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7 ...
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 2355 2355
2018 2588 2588
2019 1957 2270
2020 2687 2687
2021 3124 3124
2022 2757 2757

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 3601 3796
Mechanical Problem 1683 1711
Device Operates Differently Than Expected 1012 1012
Appropriate Term/Code Not Available 738 738
Output Problem 705 705
Gas Leak 692 724
Failure to Deliver 512 512
No Display/Image 503 503
Increase in Pressure 494 508
Device Alarm System 450 450
Infusion or Flow Problem 412 422
Unexpected Shutdown 402 407
Gas Output Problem 400 400
Device Displays Incorrect Message 359 359
Leak/Splash 308 308
Unexpected Therapeutic Results 306 309
Break 298 302
Inaccurate Delivery 290 292
Failure to Run on Battery 287 287
Physical Resistance/Sticking 261 266
Suction Failure 237 241
Decrease in Suction 223 232
Pressure Problem 219 223
Suction Problem 176 176
Energy Output Problem 136 138
Inappropriate or Unexpected Reset 133 134
Detachment of Device or Device Component 131 131
No Audible Alarm 109 110
Mechanical Jam 108 108
Intermittent Continuity 103 103
Excess Flow or Over-Infusion 100 100
Device Inoperable 94 94
Tidal Volume Fluctuations 85 85
No Pressure 82 82
Intermittent Communication Failure 69 69
Incorrect, Inadequate or Imprecise Resultor Readings 68 68
High Readings 66 66
Decrease in Pressure 59 59
Sticking 58 58
Loss of Power 56 56
Protective Measures Problem 55 55
Battery Problem 48 48
Defective Device 45 45
Insufficient Information 44 44
No Visual Prompts/Feedback 43 43
Failure of Device to Self-Test 41 41
No Flow 39 39
Display or Visual Feedback Problem 36 36
Material Integrity Problem 34 34
Computer Software Problem 32 32
Adverse Event Without Identified Device or Use Problem 30 30
Improper Flow or Infusion 28 28
Crack 28 28
Use of Device Problem 28 28
Failure to Analyze Signal 26 26
Defective Alarm 25 27
Failure to Calibrate 25 25
Loose or Intermittent Connection 23 23
Circuit Failure 20 20
Failure to Sense 20 20
Device Fell 18 18
Complete Loss of Power 17 17
Noise, Audible 15 15
Ventilation Problem in Device Environment 15 15
Contamination /Decontamination Problem 15 15
Device Tipped Over 14 14
Reset Problem 14 14
Power Problem 12 12
Calibration Problem 12 12
Improper or Incorrect Procedure or Method 12 12
Premature Discharge of Battery 12 12
Failure to Power Up 11 11
Insufficient Flow or Under Infusion 11 11
Computer Operating System Problem 11 11
Device Sensing Problem 10 10
Defective Component 10 10
Component Missing 10 10
Electrical /Electronic Property Problem 10 10
Disconnection 10 10
Computer System Security Problem 9 9
Activation Failure 9 9
Communication or Transmission Problem 8 8
Device Reprocessing Problem 8 8
Data Problem 7 7
Inaccurate Flow Rate 6 6
Device Dislodged or Dislocated 6 6
Electrical Overstress 6 6
Loss of Threshold 6 6
Unable to Obtain Readings 5 5
Inflation Problem 5 5
No Device Output 5 5
Fire 5 5
Device Handling Problem 5 5
No Apparent Adverse Event 5 5
Human-Device Interface Problem 4 4
Moisture or Humidity Problem 4 4
Intermittent Loss of Power 4 4
Complete Blockage 4 4
Partial Blockage 4 4
Detachment Of Device Component 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5873 5873
No Patient Involvement 5624 5660
No Consequences Or Impact To Patient 2626 2626
Insufficient Information 748 748
No Known Impact Or Consequence To Patient 382 657
Low Oxygen Saturation 72 72
No Information 24 24
Cardiac Arrest 22 22
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
Loss of consciousness 5 5
Tachycardia 4 4
Brain Injury 4 4
Low Blood Pressure/ Hypotension 4 4
Burn(s) 4 4
Cardiopulmonary Arrest 3 3
Hypoventilation 3 7
Respiratory Distress 3 3
Vomiting 3 3
Therapeutic Effects, Unexpected 3 5
Pneumothorax 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Respiratory Arrest 2 2
Injury 2 2
Partial thickness (Second Degree) Burn 2 2
Respiratory Failure 2 2
Oversedation 2 2
Urinary Retention 2 2
Bradycardia 2 2
Apnea 1 1
Arrhythmia 1 1
Abrasion 1 1
Airway Obstruction 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
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
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
Test Result 1 1
Intraoperative Pain 1 1
Coma 1 1
Forced Expiratory Volume Decreased 1 1
Premature Labor 1 1
Metal Related Pathology 1 1
Solid Tumour 1 1
Urinary Incontinence 1 1
Convulsion/Seizure 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Cough 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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