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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ventilator, non-continuous (respirator)
Regulation Description Noncontinuous ventilator (IPPB).
Product CodeBZD
Regulation Number 868.5905
Device Class 2


Premarket Reviews
ManufacturerDecision
3B MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
APEX MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
BMC MEDICAL.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
CIRCADIANCE, LLC
  SUBSTANTIALLY EQUIVALENT 2
DEVILBISS HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 4
RESMED CORP
  SUBSTANTIALLY EQUIVALENT 1
RESMED LTD
  SUBSTANTIALLY EQUIVALENT 8
RESMED LTD.
  SUBSTANTIALLY EQUIVALENT 1
RESMED PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 3
RESPIRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SNAPCPAP
  SUBSTANTIALLY EQUIVALENT 1
SOMNETICS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYSMED (CHINA) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 118 118
2017 148 148
2018 101 101
2019 188 188
2020 125 125
2021 2494 2494

Device Problems MDRs with this Device Problem Events in those MDRs
Degraded 1901 1901
Nonstandard Device 276 276
Patient-Device Incompatibility 137 137
Adverse Event Without Identified Device or Use Problem 122 122
Device Operates Differently Than Expected 111 111
Fire 78 78
Insufficient Information 72 72
Mechanical Problem 65 65
Disconnection 50 50
Patient Device Interaction Problem 49 49
Device Emits Odor 46 46
Break 36 36
Particulates 32 32
Device Issue 30 30
Device Displays Incorrect Message 28 28
No Display/Image 25 25
Contamination 23 23
Loose or Intermittent Connection 20 20
Pressure Problem 20 20
Device Contamination with Chemical or Other Material 20 20
Detachment of Device or Device Component 19 19
Thermal Decomposition of Device 18 18
Noise, Audible 16 16
Defective Device 15 15
Fitting Problem 15 15
Product Quality Problem 15 15
Connection Problem 15 15
Device Markings/Labelling Problem 15 15
Material Integrity Problem 12 12
Smoking 12 12
Use of Device Problem 11 11
Obstruction of Flow 11 11
No Audible Alarm 11 11
Overheating of Device 11 11
Output Problem 11 11
Improper or Incorrect Procedure or Method 10 10
Defective Component 10 10
Therapeutic or Diagnostic Output Failure 9 9
Material Fragmentation 9 9
Material Separation 8 8
Device Inoperable 8 8
Electrical /Electronic Property Problem 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Moisture or Humidity Problem 8 8
Unintended Movement 7 7
Contamination /Decontamination Problem 7 7
Leak/Splash 7 7
Device Stops Intermittently 6 6
Component Missing 6 6
Device Slipped 5 5
Fluid Leak 5 5
Complete Blockage 5 5
Power Problem 5 5
Physical Resistance/Sticking 5 5
No Pressure 4 4
Material Disintegration 4 4
Melted 4 4
Failure to Power Up 4 4
Inaccurate Delivery 4 4
Device Dislodged or Dislocated 4 4
Gas Leak 4 4
Human-Device Interface Problem 4 4
Improper Flow or Infusion 4 4
Appropriate Term/Code Not Available 4 4
Material Split, Cut or Torn 3 3
Unexpected Shutdown 3 3
Infusion or Flow Problem 3 3
Crack 3 3
Difficult To Position 3 3
Microbial Contamination of Device 3 3
Temperature Problem 3 3
Compatibility Problem 3 3
Erratic or Intermittent Display 3 3
Increase in Pressure 3 3
Partial Blockage 3 3
Computer Software Problem 2 2
Device Alarm System 2 2
Inadequacy of Device Shape and/or Size 2 2
Decrease in Pressure 2 2
Biocompatibility 2 2
Electromagnetic Compatibility Problem 2 2
Failure of Device to Self-Test 2 2
Contamination of Device Ingredient or Reagent 2 2
Failure to Calibrate 2 2
Cut In Material 2 2
Loss of Power 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Use of Incorrect Control Settings 2 2
Excess Flow or Over-Infusion 2 2
Inadequate Instructions for Healthcare Professional 2 2
Unsealed Device Packaging 2 2
Material Protrusion/Extrusion 2 2
No Flow 2 2
Protective Measures Problem 2 2
Device Operational Issue 2 2
Sparking 2 2
Failure to Deliver 2 2
Device Tipped Over 1 1
Deformation Due to Compressive Stress 1 1
Communication or Transmission Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1264 1264
Headache 208 209
Cancer 201 201
Cough 180 180
Dyspnea 173 173
No Consequences Or Impact To Patient 152 152
No Patient Involvement 146 146
Unspecified Respiratory Problem 119 119
No Known Impact Or Consequence To Patient 115 115
Asthma 87 87
Insufficient Information 78 78
Respiratory Tract Infection 71 71
Sore Throat 70 70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 70 70
Dizziness 66 66
Nodule 58 58
Pneumonia 48 48
Chest Pain 48 48
Unspecified Infection 45 45
Skin Inflammation/ Irritation 39 39
Sleep Dysfunction 37 37
Pain 36 36
Fatigue 35 35
Nausea 34 34
Low Oxygen Saturation 28 28
Bronchitis 26 26
Injury 25 25
Death 24 24
Swelling/ Edema 23 23
Inflammation 20 20
Hypersensitivity/Allergic reaction 19 19
No Information 19 19
Solid Tumour 18 18
Unspecified Kidney or Urinary Problem 18 18
Chronic Obstructive Pulmonary Disease (COPD) 18 18
Discomfort 16 16
Breast Cancer 16 16
Patient Problem/Medical Problem 15 15
Epistaxis 15 15
Wheezing 14 14
Unspecified Eye / Vision Problem 14 14
Burning Sensation 14 14
Respiratory Distress 14 14
Vomiting 13 13
Scar Tissue 12 12
Stroke/CVA 12 12
Atrial Fibrillation 12 12
No Code Available 12 13
Rash 12 12
Unspecified Heart Problem 11 11
Bacterial Infection 11 11
Cardiac Arrest 11 11
Hypoxia 11 11
Itching Sensation 11 11
Chemical Exposure 10 10
Burn(s) 10 10
Irritability 9 9
Choking 8 8
Myocardial Infarction 8 8
Muscle Weakness 8 8
Heart Failure/Congestive Heart Failure 8 8
Lymphoma 7 7
Vertigo 7 7
Abscess 7 7
Apnea 7 7
Tooth Fracture 7 7
Fibrosis 7 7
Dry Mouth 6 6
Confusion/ Disorientation 6 6
Pulmonary Embolism 6 6
Cyst(s) 6 6
High Blood Pressure/ Hypertension 6 6
Fever 6 6
Hearing Impairment 6 6
Dry Eye(s) 5 5
Aspiration/Inhalation 5 5
Thrombosis/Thrombus 5 5
Convulsion/Seizure 5 5
Eye Infections 5 5
Weight Changes 5 5
Obstruction/Occlusion 5 5
Foreign Body In Patient 5 5
Unspecified Hepatic or Biliary Problem 5 5
Arrhythmia 5 5
Abdominal Pain 4 4
Tachycardia 4 4
Red Eye(s) 4 4
Tissue Damage 4 4
Blurred Vision 4 4
Visual Impairment 4 4
Anxiety 4 4
Eye Pain 4 4
Pulmonary Hypertension 4 4
Swollen Lymph Nodes/Glands 4 4
Respiratory Failure 4 4
Ambulation Difficulties 4 4
Cognitive Changes 4 4
Abrasion 4 4
Airway Obstruction 4 4
Erythema 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Compass Health Brands (Corporate Office) I Aug-20-2018
2 Galemed Corporation I Dec-20-2019
3 Philips Respironics, Inc. I Jul-13-2021
4 Resmed Corporation II Aug-16-2016
5 TELEFLEX-MORRISVILLE I Nov-07-2019
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