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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 4030 4030

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 5238 5433
Mechanical Problem 3300 3328
Failure to Run on Battery 2233 2233
No Display/Image 1690 1690
Device Operates Differently Than Expected 1660 1660
Appropriate Term/Code Not Available 1219 1219
Output Problem 1056 1056
Gas/Air Leak 998 1030
Insufficient Flow or Under Infusion 941 941
Failure to Deliver 869 869
Unexpected Therapeutic Results 748 751
Increase in Pressure 744 758
Unexpected Shutdown 686 691
Gas Output Problem 686 686
Device Displays Incorrect Message 683 683
Device Alarm System 646 646
Infusion or Flow Problem 579 589
Power Problem 532 532
Leak/Splash 506 506
Pressure Problem 463 467
Inaccurate Delivery 443 445
Break 410 414
Electrical /Electronic Property Problem 366 366
Physical Resistance/Sticking 307 312
Suction Failure 291 295
Suction Problem 255 255
Decrease in Suction 253 262
Failure to Power Up 251 251
Device Inoperable 248 248
Tidal Volume Fluctuations 206 206
Inappropriate or Unexpected Reset 205 206
No Visual Prompts/Feedback 187 187
Intermittent Continuity 175 175
Detachment of Device or Device Component 160 160
No Audible Alarm 151 152
Energy Output Problem 144 146
Excess Flow or Over-Infusion 139 139
Insufficient Information 128 128
Decrease in Pressure 124 124
Intermittent Communication Failure 115 115
Mechanical Jam 113 113
Loss of Power 109 109
No Pressure 103 103
Complete Loss of Power 97 97
Battery Problem 95 95
Sticking 94 94
Adverse Event Without Identified Device or Use Problem 80 80
No Flow 79 79
Protective Measures Problem 72 72
Incorrect, Inadequate or Imprecise Result or Readings 71 71

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16991 16991
No Patient Involvement 7389 7425
No Consequences Or Impact To Patient 3412 3412
Insufficient Information 812 812
No Known Impact Or Consequence To Patient 758 1033
Low Oxygen Saturation 140 140
No Information 39 39
Death 35 35
Awareness during Anaesthesia 32 32
Cardiac Arrest 30 30
Patient Problem/Medical Problem 16 16
No Code Available 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Hypoxia 13 13
Low Blood Pressure/ Hypotension 12 12
Cyanosis 11 11
Bradycardia 8 8
Pneumothorax 8 8
Burn(s) 7 7
Brain Injury 6 6
Loss of consciousness 6 6
Vomiting 6 6
Tachycardia 5 5
Respiratory Distress 4 4
Therapeutic Effects, Unexpected 4 6
Hypoventilation 4 8
Cardiopulmonary Arrest 4 4
Apnea 4 4
Injury 4 4
Respiratory Arrest 3 3
Nausea 3 3
Unspecified Respiratory Problem 3 3
Coma 3 3
High Blood Pressure/ Hypertension 3 3
Oversedation 3 3
Convulsion/Seizure 2 2
Partial thickness (Second Degree) Burn 2 2
Respiratory Failure 2 2
Capsular Contracture 2 2
Cough 2 2
Laceration(s) 2 2
Airway Obstruction 2 2
Urinary Retention 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Lethargy 1 1
Sleep Dysfunction 1 1
Premature Labor 1 1
Complaint, Ill-Defined 1 1
Intraoperative Pain 1 1
Solid Tumour 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 Sep-04-2024
55 Mindray DS USA, Inc. dba Mindray North America II Mar-02-2018
56 Mindray DS USA, Inc. dba Mindray North America II Aug-30-2016
57 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Apr-08-2010
58 Penlon, Ltd. II Mar-26-2012
59 Philips Healthcare Inc. II Aug-24-2010
60 Spacelabs Healthcare, Llc II Dec-27-2010
61 Spacelabs Healthcare, Llc II Jul-29-2010
62 Spacelabs Healthcare, Ltd. I Nov-21-2017
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