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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 3
DRÄGERWERK AG CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
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 2589 2589
2019 1957 2270
2020 2687 2687
2021 3123 3123
2022 4350 4350
2023 5596 5596
2024 1426 1426

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 4908 5103
Mechanical Problem 2861 2889
Failure to Run on Battery 1863 1863
No Display/Image 1371 1371
Device Operates Differently Than Expected 1012 1012
Output Problem 994 994
Gas/Air Leak 916 948
Failure to Deliver 790 790
Appropriate Term/Code Not Available 739 739
Increase in Pressure 684 698
Unexpected Shutdown 626 631
Gas Output Problem 618 618
Insufficient Flow or Under Infusion 602 602
Unexpected Therapeutic Results 567 570
Infusion or Flow Problem 507 517
Device Alarm System 451 451
Inaccurate Delivery 417 419
Device Displays Incorrect Message 380 380
Leak/Splash 334 334
Break 331 335
Power Problem 326 326
Physical Resistance/Sticking 301 306
Suction Failure 291 295
Pressure Problem 261 265
Decrease in Suction 251 260
Electrical /Electronic Property Problem 248 248
Suction Problem 194 194
Inappropriate or Unexpected Reset 187 188
No Visual Prompts/Feedback 168 168
Failure to Power Up 168 168
Intermittent Continuity 160 160
Detachment of Device or Device Component 158 158
No Audible Alarm 147 148
Energy Output Problem 144 146
Mechanical Jam 108 108
Insufficient Information 107 107
Intermittent Communication Failure 107 107
Excess Flow or Over-Infusion 107 107
Decrease in Pressure 105 105
Device Inoperable 94 94
No Pressure 88 88
Tidal Volume Fluctuations 87 87
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Protective Measures Problem 68 68
Complete Loss of Power 68 68
Battery Problem 67 67
High Readings 66 66
Adverse Event Without Identified Device or Use Problem 64 64
Loss of Power 60 60
Sticking 58 58
No Flow 58 58
Display or Visual Feedback Problem 56 56
Use of Device Problem 51 51
Defective Device 47 47
Failure to Analyze Signal 42 42
Failure of Device to Self-Test 42 42
Failure to Sense 35 35
Computer Software Problem 35 35
Material Integrity Problem 34 34
Improper Flow or Infusion 33 33
Circuit Failure 33 33
Crack 29 29
Defective Alarm 26 28
Failure to Calibrate 26 26
Calibration Problem 25 25
Loose or Intermittent Connection 23 23
Contamination /Decontamination Problem 22 22
Reset Problem 21 21
Premature Discharge of Battery 21 21
Device Fell 18 18
Noise, Audible 16 16
Disconnection 16 16
Ventilation Problem in Device Environment 15 15
Device Sensing Problem 15 15
No Apparent Adverse Event 14 14
Activation Failure 14 14
Device Tipped Over 14 14
Improper or Incorrect Procedure or Method 14 14
Intermittent Loss of Power 12 12
Electrical Overstress 12 12
Computer Operating System Problem 11 11
Component Missing 11 11
Defective Component 10 10
Data Problem 10 10
Computer System Security Problem 9 9
Erratic or Intermittent Display 9 9
Device Reprocessing Problem 9 9
Fire 9 9
No Device Output 8 8
Degraded 8 8
Device Handling Problem 8 8
Communication or Transmission Problem 8 8
Complete Blockage 7 7
Inaccurate Flow Rate 7 7
Fluid/Blood Leak 6 6
Failure to Reset 6 6
Loss of Threshold 6 6
Incorrect Interpretation of Signal 6 6
Device-Device Incompatibility 6 6
Device Dislodged or Dislocated 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14394 14394
No Patient Involvement 5624 5660
No Consequences Or Impact To Patient 2626 2626
Insufficient Information 808 808
No Known Impact Or Consequence To Patient 382 657
Low Oxygen Saturation 106 106
Cardiac Arrest 28 28
Awareness during Anaesthesia 25 25
No Information 24 24
Death 20 20
Patient Problem/Medical Problem 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
No Code Available 11 11
Hypoxia 11 11
Cyanosis 9 9
Low Blood Pressure/ Hypotension 6 6
Bradycardia 6 6
Loss of consciousness 6 6
Burn(s) 5 5
Brain Injury 5 5
Vomiting 5 5
Pneumothorax 4 4
Tachycardia 4 4
Therapeutic Effects, Unexpected 3 5
Respiratory Distress 3 3
Cardiopulmonary Arrest 3 3
Apnea 3 3
Hypoventilation 3 7
Oversedation 3 3
Unspecified Respiratory Problem 3 3
Cough 2 2
Respiratory Arrest 2 2
Convulsion/Seizure 2 2
Partial thickness (Second Degree) Burn 2 2
Coma 2 2
Injury 2 2
Respiratory Failure 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
Dizziness 1 1
Cardiac Tamponade 1 1
Anxiety 1 1
Complaint, Ill-Defined 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
Capsular Contracture 1 1
Suture Abrasion 1 1
Low Cardiac Output 1 1
Sudden Cardiac Death 1 1
Sleep Dysfunction 1 1
Electric Shock 1 1
Lethargy 1 1
Loss Of Pulse 1 1
Bronchospasm 1 1
Overinflation of Lung 1 1
Forced Expiratory Volume Decreased 1 1
Premature Labor 1 1
Respiratory Acidosis 1 1
Test Result 1 1
Intraoperative Pain 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Blood or Lymphatic 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 Del Mar Reynolds Medical, Ltd. II May-16-2017
2 Draeger Medical, Inc. I Apr-18-2024
3 Draeger Medical, Inc. II Jan-14-2022
4 Draeger Medical, Inc. II Jun-19-2018
5 Draeger Medical, Inc. I May-08-2018
6 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
7 GE Healthcare, LLC II Jul-20-2022
8 GE Healthcare, LLC I Jul-19-2022
9 GE Healthcare, LLC II Jun-24-2022
10 GE Healthcare, LLC II Sep-30-2021
11 GE Healthcare, LLC II Oct-30-2020
12 GE Healthcare, LLC I Jan-23-2020
13 GE Healthcare, LLC II Dec-17-2019
14 GE Healthcare, LLC II Nov-09-2018
15 GE Healthcare, LLC II Mar-26-2018
16 GE Healthcare, LLC II May-24-2017
17 GE Medical Systems China Co., Ltd. II Aug-30-2018
18 GE Medical Systems China Co., Ltd. II Feb-09-2018
19 Getinge Group Logistics America, LLC II Mar-05-2021
20 Getinge Usa Sales Inc II Feb-06-2024
21 Getinge Usa Sales Inc I Jan-26-2023
22 Getinge Usa Sales Inc II Dec-07-2022
23 Getinge Usa Sales Inc I Jun-23-2022
24 Getinge Usa Sales Inc I Jan-10-2022
25 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
26 Spacelabs Healthcare, Ltd. I Nov-21-2017
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