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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
ADVANCED INSTRUMENTATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K120075  AM-6000 ANESTHESIA MACHINE
CODONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP., PATIENT MONITORING DIVISION
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 10
DRAEGER MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
DRÄGERWERK AG CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE FINLAND OY
  SUBSTANTIALLY EQUIVALENT 3
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 5
MCKESSON TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY DS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORICARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ANESTHESIA CARE
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
THORNHILL RESEARCH INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 278 278
2015 572 572
2016 2135 2135
2017 2355 2355
2018 2589 2589
2019 1957 2270
2020 2687 2687
2021 3123 3123
2022 4350 4350
2023 5596 5596
2024 2411 2411

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 5017 5212
Mechanical Problem 3136 3164
Failure to Run on Battery 2025 2025
Device Operates Differently Than Expected 1660 1660
No Display/Image 1518 1518
Appropriate Term/Code Not Available 1219 1219
Output Problem 1014 1014
Gas/Air Leak 955 987
Failure to Deliver 825 825
Insufficient Flow or Under Infusion 752 752
Increase in Pressure 723 737
Device Displays Incorrect Message 683 683
Unexpected Shutdown 654 659
Device Alarm System 646 646
Gas Output Problem 644 644
Unexpected Therapeutic Results 641 644
Infusion or Flow Problem 556 566
Leak/Splash 497 497
Pressure Problem 451 455
Inaccurate Delivery 432 434
Break 410 414
Power Problem 401 401
Physical Resistance/Sticking 301 306
Suction Failure 291 295
Electrical /Electronic Property Problem 280 280
Suction Problem 255 255
Decrease in Suction 253 262
Device Inoperable 248 248
Tidal Volume Fluctuations 204 204
Failure to Power Up 202 202
Inappropriate or Unexpected Reset 201 202
No Visual Prompts/Feedback 178 178
Intermittent Continuity 164 164
Detachment of Device or Device Component 160 160
No Audible Alarm 151 152
Energy Output Problem 144 146
Excess Flow or Over-Infusion 133 133
Insufficient Information 119 119
Decrease in Pressure 116 116
Mechanical Jam 113 113
Intermittent Communication Failure 112 112
Loss of Power 109 109
Sticking 94 94
No Pressure 93 93
Battery Problem 90 90
Complete Loss of Power 86 86
Adverse Event Without Identified Device or Use Problem 78 78
No Flow 74 74
Incorrect, Inadequate or Imprecise Result or Readings 71 71
Protective Measures Problem 70 70
High Readings 66 66
Display or Visual Feedback Problem 61 61
Failure of Device to Self-Test 61 61
Use of Device Problem 55 55
Computer Software Problem 52 52
Defective Device 49 49
Failure to Analyze Signal 43 43
Improper Flow or Infusion 41 41
Failure to Sense 37 37
Defective Alarm 35 37
Material Integrity Problem 35 35
Reset Problem 33 33
Circuit Failure 33 33
Crack 33 33
Calibration Problem 30 30
Ventilation Problem in Device Environment 28 28
Failure to Calibrate 27 27
Loose or Intermittent Connection 26 26
Computer Operating System Problem 25 25
Data Problem 24 24
Premature Discharge of Battery 23 23
Improper or Incorrect Procedure or Method 23 23
Device Stops Intermittently 22 22
Contamination /Decontamination Problem 22 22
Noise, Audible 21 21
Device Sensing Problem 20 20
Disconnection 20 20
Device Fell 19 19
Device Tipped Over 18 18
Nonstandard Device 18 18
No Apparent Adverse Event 17 17
Air Leak 16 16
Defective Component 15 15
Activation Failure 15 15
Intermittent Loss of Power 15 15
No Device Output 14 14
Partial Blockage 14 14
Complete Blockage 14 14
Device Dislodged or Dislocated 13 13
Electrical Overstress 12 12
Fire 12 12
Component Missing 11 11
Inflation Problem 10 10
Degraded 10 10
Communication or Transmission Problem 10 10
Computer System Security Problem 9 9
Connection Problem 9 9
Device-Device Incompatibility 9 9
Device Handling Problem 9 9
Device Reprocessing Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15378 15378
No Patient Involvement 7389 7425
No Consequences Or Impact To Patient 3412 3412
Insufficient Information 809 809
No Known Impact Or Consequence To Patient 758 1033
Low Oxygen Saturation 138 138
No Information 39 39
Death 35 35
Awareness during Anaesthesia 32 32
Cardiac Arrest 29 29
Patient Problem/Medical Problem 16 16
No Code Available 15 15
Hypoxia 13 13
Low Blood Pressure/ Hypotension 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Cyanosis 11 11
Pneumothorax 8 8
Bradycardia 8 8
Burn(s) 7 7
Loss of consciousness 6 6
Brain Injury 6 6
Vomiting 6 6
Tachycardia 5 5
Therapeutic Effects, Unexpected 4 6
Respiratory Distress 4 4
Hypoventilation 4 8
Cardiopulmonary Arrest 4 4
Apnea 4 4
Injury 4 4
Oversedation 3 3
Coma 3 3
High Blood Pressure/ Hypertension 3 3
Respiratory Arrest 3 3
Unspecified Respiratory Problem 3 3
Laceration(s) 2 2
Nausea 2 2
Urinary Retention 2 2
Airway Obstruction 2 2
Convulsion/Seizure 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Cough 2 2
Partial thickness (Second Degree) Burn 2 2
Respiratory Failure 2 2
Suture Abrasion 1 1
Low Cardiac Output 1 1
Sudden Cardiac Death 1 1
Sleep Dysfunction 1 1
Burn, Thermal 1 1
Electric Shock 1 1
Lethargy 1 1
Loss Of Pulse 1 1
Blood Loss 1 1
Bronchospasm 1 1
Overinflation of Lung 1 1
Reaction 1 1
Dizziness 1 1
Cardiac Tamponade 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Test Result 1 1
Unspecified Blood or Lymphatic problem 1 1
Asystole 1 1
Forced Expiratory Volume Decreased 1 1
Premature Labor 1 1
Respiratory Acidosis 1 1
Intraoperative Pain 1 1
Abrasion 1 1
Arrhythmia 1 1
Capsular Contracture 1 1
Dyspnea 1 1
Emotional Changes 1 1
Eye Injury 1 1
Bone Fracture(s) 1 1
Head Injury 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Blurred Vision 1 1
Respiratory Distress Syndrome of Newborns 1 1
Swelling 1 1
Pulmonary Edema 1 1
Pulmonary Insufficiency 1 1
Failure of Implant 1 1
Metal Related Pathology 1 1
Solid Tumour 1 1
Urinary Incontinence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accutron Inc I Oct-09-2012
2 Beckman Coulter Inc. II Aug-30-2016
3 Blease Medical Equipment, Ltd. II Apr-16-2010
4 Del Mar Reynolds Medical, Ltd. II May-16-2017
5 Del Mar Reynolds Medical, Ltd. I Nov-20-2013
6 Del Mar Reynolds Medical, Ltd. II Dec-19-2012
7 Draeger Medical Systems, Inc. II Sep-23-2010
8 Draeger Medical, Inc. I Apr-18-2024
9 Draeger Medical, Inc. II Jan-14-2022
10 Draeger Medical, Inc. II Jun-19-2018
11 Draeger Medical, Inc. I May-08-2018
12 Draeger Medical, Inc. I Dec-12-2015
13 Draeger Medical, Inc. II Jul-27-2015
14 Draeger Medical, Inc. I Oct-10-2013
15 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
16 GE Healthcare II Apr-02-2015
17 GE Healthcare II Jul-30-2009
18 GE Healthcare II Jun-23-2009
19 GE Healthcare, LLC II Jul-20-2022
20 GE Healthcare, LLC I Jul-19-2022
21 GE Healthcare, LLC II Jun-24-2022
22 GE Healthcare, LLC II Sep-30-2021
23 GE Healthcare, LLC II Oct-30-2020
24 GE Healthcare, LLC I Jan-23-2020
25 GE Healthcare, LLC II Dec-17-2019
26 GE Healthcare, LLC II Nov-09-2018
27 GE Healthcare, LLC II Mar-26-2018
28 GE Healthcare, LLC II May-24-2017
29 GE Healthcare, LLC II Dec-14-2016
30 GE Healthcare, LLC I Oct-15-2013
31 GE Healthcare, LLC I Oct-15-2013
32 GE Healthcare, LLC II Sep-06-2013
33 GE Healthcare, LLC II Jun-03-2013
34 GE Healthcare, LLC II Oct-06-2010
35 GE Medical Systems China Co., Ltd. II Aug-30-2018
36 GE Medical Systems China Co., Ltd. II Feb-09-2018
37 GE Medical Systems, LLC II Apr-22-2016
38 GE Medical Systems, LLC II Apr-13-2016
39 GE Medical Systems, LLC II Jan-21-2016
40 Ge Healthcare, Llc I May-11-2010
41 Getinge Group Logistics America, LLC II Mar-05-2021
42 Getinge Usa Sales Inc I May-31-2024
43 Getinge Usa Sales Inc II Feb-06-2024
44 Getinge Usa Sales Inc I Jan-26-2023
45 Getinge Usa Sales Inc II Dec-07-2022
46 Getinge Usa Sales Inc I Jun-23-2022
47 Getinge Usa Sales Inc I Jan-10-2022
48 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
49 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
50 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
51 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
52 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
53 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
54 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
55 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
56 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
57 Penlon, Ltd. II Mar-26-2012
58 Philips Healthcare Inc. II Aug-24-2010
59 Spacelabs Healthcare, Llc II Dec-27-2010
60 Spacelabs Healthcare, Llc II Jul-29-2010
61 Spacelabs Healthcare, Ltd. I Nov-21-2017
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