• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device ventilator, emergency, manual (resuscitator)
Product CodeBTM
Regulation Number 868.5915
Device Class 2


Premarket Reviews
ManufacturerDecision
ARCHEON
  SUBSTANTIALLY EQUIVALENT 1
SAFE BVM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 46 46
2020 26 26
2021 42 42
2022 35 35
2023 48 48
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Inflation Problem 18 18
Break 17 17
Defective Device 13 13
Defective Component 11 11
Deflation Problem 10 10
Detachment of Device or Device Component 10 10
Gas/Air Leak 10 10
Pressure Problem 9 9
Device Damaged Prior to Use 9 9
Connection Problem 7 7
Component Missing 7 7
Physical Resistance/Sticking 6 6
Incomplete or Inadequate Connection 5 5
Material Integrity Problem 5 5
No Flow 4 4
Difficult to Open or Close 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unintended Deflation 4 4
Material Split, Cut or Torn 4 4
Failure to Deliver 4 4
Loose or Intermittent Connection 4 4
Material Puncture/Hole 3 3
Mechanical Problem 3 3
Crack 3 3
Fluid/Blood Leak 3 3
Fitting Problem 3 3
Use of Device Problem 3 3
Material Deformation 3 3
Packaging Problem 2 2
Material Twisted/Bent 2 2
Infusion or Flow Problem 2 2
Device Handling Problem 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Disconnect 2 2
Disconnection 2 2
Failure to Deliver Energy 1 1
Leak/Splash 1 1
Device Alarm System 1 1
Complete Blockage 1 1
Collapse 1 1
Misconnection 1 1
Moisture Damage 1 1
Nonstandard Device 1 1
No Device Output 1 1
Increase in Pressure 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Incorrect Measurement 1 1
Activation, Positioning or Separation Problem 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Unexpected Therapeutic Results 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Incomplete or Missing Packaging 1 1
Patient Device Interaction Problem 1 1
Failure to Seal 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Suction Failure 1 1
Premature Separation 1 1
Missing Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Improper Flow or Infusion 1 1
Device Dislodged or Dislocated 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Mechanical Jam 1 1
No Pressure 1 1
Optical Distortion 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
No Known Impact Or Consequence To Patient 36 36
Insufficient Information 24 24
Low Oxygen Saturation 18 18
No Consequences Or Impact To Patient 15 15
Cardiac Arrest 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
No Patient Involvement 10 10
Decreased Respiratory Rate 5 5
Respiratory Arrest 4 4
Respiratory Insufficiency 4 4
Death 4 4
Hypoxia 4 4
Loss of consciousness 3 3
Respiratory Failure 2 2
Bradycardia 2 2
Hypoventilation 2 2
Vomiting 2 2
Unspecified Respiratory Problem 2 2
Cerebral Edema 2 2
No Code Available 2 2
Missing Value Reason 1 1
No Information 1 1
Diminished Pulse Pressure 1 1
Foreign Body In Patient 1 1
Asystole 1 1
Cardiovascular Insufficiency 1 1
Unspecified Tissue Injury 1 1
Anemia 1 1
Failure of Implant 1 1
Pneumothorax 1 1
Respiratory Distress 1 1
Dyspnea 1 1
Endocarditis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 SunMed Holdings, LLC II Nov-21-2023
2 Vyaire Medical I Feb-25-2024
-
-