TPLC - Total Product Life Cycle

• Device: ventilator, emergency, manual (resuscitator)
• Product Code: BTM
• Regulation Number: 868.5915
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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	12	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inflation Problem	19	19
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
Component Missing	7	7
Connection Problem	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
Unintended Deflation	4	4
Material Split, Cut or Torn	4	4
Therapeutic or Diagnostic Output Failure	4	4
Failure to Deliver	4	4
Loose or Intermittent Connection	4	4
Mechanical Problem	3	3
Disconnection	3	3
Crack	3	3
Material Puncture/Hole	3	3
Use of Device Problem	3	3
Fluid/Blood Leak	3	3
Fitting Problem	3	3
Material Deformation	3	3
Packaging Problem	2	2
Device Handling Problem	2	2
Material Twisted/Bent	2	2
Infusion or Flow 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
Incomplete or Missing Packaging	1	1
Obstruction of Flow	1	1
Structural Problem	1	1
Expiration Date Error	1	1
Unexpected Therapeutic Results	1	1
Product Quality Problem	1	1
Material Too Rigid or Stiff	1	1
Improper or Incorrect Procedure or Method	1	1
Suction Problem	1	1
Device Alarm System	1	1
Failure to Deliver Energy	1	1
Complete Blockage	1	1
Collapse	1	1
Contamination	1	1
Misconnection	1	1
Moisture Damage	1	1
Nonstandard Device	1	1
No Device Output	1	1
Increase in Pressure	1	1
Incorrect Measurement	1	1
Leak/Splash	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Mechanical Jam	1	1
No Pressure	1	1
Optical Distortion	1	1
Output Problem	1	1
Device Dislodged or Dislocated	1	1
Improper Flow or Infusion	1	1
Activation, Positioning or Separation Problem	1	1
Device Markings/Labelling Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Patient Device Interaction Problem	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Failure to Seal	1	1
Suction Failure	1	1
Premature Separation	1	1
Missing Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	45	45
No Known Impact Or Consequence To Patient	36	36
Insufficient Information	25	25
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