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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
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 1426 1426

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 4909 5104
Mechanical Problem 3055 3083
Failure to Run on Battery 1863 1863
Device Operates Differently Than Expected 1660 1660
No Display/Image 1437 1437
Appropriate Term/Code Not Available 1219 1219
Output Problem 994 994
Gas/Air Leak 923 955
Failure to Deliver 802 802
Increase in Pressure 700 714
Device Displays Incorrect Message 683 683
Device Alarm System 646 646
Unexpected Shutdown 626 631
Gas Output Problem 624 624
Insufficient Flow or Under Infusion 603 603
Unexpected Therapeutic Results 567 570
Infusion or Flow Problem 539 549
Leak/Splash 492 492
Pressure Problem 437 441
Inaccurate Delivery 427 429
Break 410 414
Power Problem 334 334
Physical Resistance/Sticking 301 306
Suction Failure 291 295
Electrical /Electronic Property Problem 257 257
Suction Problem 255 255
Decrease in Suction 253 262
Device Inoperable 248 248
Tidal Volume Fluctuations 204 204
Inappropriate or Unexpected Reset 198 199
Failure to Power Up 177 177
No Visual Prompts/Feedback 168 168
Intermittent Continuity 160 160
Detachment of Device or Device Component 159 159
No Audible Alarm 151 152
Energy Output Problem 144 146
Excess Flow or Over-Infusion 131 131
Mechanical Jam 113 113
Insufficient Information 112 112
Decrease in Pressure 109 109
Loss of Power 109 109
Intermittent Communication Failure 107 107
Sticking 94 94
No Pressure 89 89
Battery Problem 88 88
No Flow 71 71
Incorrect, Inadequate or Imprecise Result or Readings 71 71
Adverse Event Without Identified Device or Use Problem 70 70
Protective Measures Problem 70 70
Complete Loss of Power 68 68
High Readings 66 66
Display or Visual Feedback Problem 61 61
Failure of Device to Self-Test 61 61
Use of Device Problem 53 53
Computer Software Problem 50 50
Defective Device 49 49
Failure to Analyze Signal 42 42
Improper Flow or Infusion 40 40
Failure to Sense 37 37
Defective Alarm 35 37
Material Integrity Problem 35 35
Circuit Failure 33 33
Crack 33 33
Reset Problem 32 32
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 19 19
Nonstandard Device 18 18
Device Tipped Over 18 18
Device Fell 18 18
Air Leak 16 16
Defective Component 15 15
No Apparent Adverse Event 15 15
Activation Failure 14 14
Partial Blockage 14 14
No Device Output 13 13
Device Dislodged or Dislocated 13 13
Electrical Overstress 12 12
Intermittent Loss of Power 12 12
Fire 12 12
Component Missing 11 11
Inflation Problem 10 10
Communication or Transmission Problem 10 10
Computer System Security Problem 9 9
Connection Problem 9 9
Fluid/Blood Leak 9 9
Erratic or Intermittent Display 9 9
Device Reprocessing Problem 9 9
Detachment Of Device Component 9 9
Device Damaged Prior to Use 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14394 14394
No Patient Involvement 7389 7425
No Consequences Or Impact To Patient 3412 3412
Insufficient Information 808 808
No Known Impact Or Consequence To Patient 758 1033
Low Oxygen Saturation 135 135
No Information 39 39
Death 35 35
Awareness during Anaesthesia 32 32
Cardiac Arrest 28 28
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 5 5
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
Unspecified Respiratory Problem 3 3
Laceration(s) 2 2
Nausea 2 2
Urinary Retention 2 2
Convulsion/Seizure 2 2
Partial thickness (Second Degree) Burn 2 2
Cough 2 2
Respiratory Arrest 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 Mental, Emotional or Behavioural Problem 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
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
Arrhythmia 1 1
Abrasion 1 1
Airway Obstruction 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
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. II Jan-14-2022
9 Draeger Medical, Inc. II Jun-19-2018
10 Draeger Medical, Inc. I May-08-2018
11 Draeger Medical, Inc. I Dec-12-2015
12 Draeger Medical, Inc. II Jul-27-2015
13 Draeger Medical, Inc. I Oct-10-2013
14 Draegerwerk Ag & Co. Kgaa II Feb-01-2024
15 GE Healthcare II Apr-02-2015
16 GE Healthcare II Jul-30-2009
17 GE Healthcare II Jun-23-2009
18 GE Healthcare, LLC II Jul-20-2022
19 GE Healthcare, LLC I Jul-19-2022
20 GE Healthcare, LLC II Jun-24-2022
21 GE Healthcare, LLC II Sep-30-2021
22 GE Healthcare, LLC II Oct-30-2020
23 GE Healthcare, LLC I Jan-23-2020
24 GE Healthcare, LLC II Dec-17-2019
25 GE Healthcare, LLC II Nov-09-2018
26 GE Healthcare, LLC II Mar-26-2018
27 GE Healthcare, LLC II May-24-2017
28 GE Healthcare, LLC II Dec-14-2016
29 GE Healthcare, LLC I Oct-15-2013
30 GE Healthcare, LLC I Oct-15-2013
31 GE Healthcare, LLC II Sep-06-2013
32 GE Healthcare, LLC II Jun-03-2013
33 GE Healthcare, LLC II Oct-06-2010
34 GE Medical Systems China Co., Ltd. II Aug-30-2018
35 GE Medical Systems China Co., Ltd. II Feb-09-2018
36 GE Medical Systems, LLC II Apr-22-2016
37 GE Medical Systems, LLC II Apr-13-2016
38 GE Medical Systems, LLC II Jan-21-2016
39 Ge Healthcare, Llc I May-11-2010
40 Getinge Group Logistics America, LLC II Mar-05-2021
41 Getinge Usa Sales Inc II Feb-06-2024
42 Getinge Usa Sales Inc I Jan-26-2023
43 Getinge Usa Sales Inc II Dec-07-2022
44 Getinge Usa Sales Inc I Jun-23-2022
45 Getinge Usa Sales Inc I Jan-10-2022
46 MCKESSON TECHNOLOGIES INC. I Mar-05-2014
47 Maquet Cardiovascular Us Sales, Llc I Feb-22-2016
48 Maquet Cardiovascular Us Sales, Llc II Jul-15-2015
49 Maquet Cardiovascular Us Sales, Llc I Jun-08-2015
50 Maquet Cardiovascular Us Sales, Llc I Jul-06-2012
51 Mindray DS USA, Inc. d.b.a. Mindray North America I Nov-16-2012
52 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
53 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
54 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
55 Penlon, Ltd. II Mar-26-2012
56 Philips Healthcare Inc. II Aug-24-2010
57 Spacelabs Healthcare, Llc II Dec-27-2010
58 Spacelabs Healthcare, Llc II Jul-29-2010
59 Spacelabs Healthcare, Ltd. I Nov-21-2017
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