TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
FLEXICARE MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FOREMOUNT ENTERPRISE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2017	56	56
2018	53	53
2019	46	46
2020	26	26
2021	42	42
2022	18	18

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	19	19
Inflation Problem	16	16
Device Damaged Prior to Use	13	13
Defective Device	13	13
Component Missing	12	12
Device Operates Differently Than Expected	12	12
Defective Component	12	12
Appropriate Term/Code Not Available	12	12
Connection Problem	11	11
Device Issue	9	9
Device Operational Issue	9	9
Fitting Problem	8	8
Material Deformation	7	7
Device Dislodged or Dislocated	6	6
Gas Leak	6	6
Detachment of Device or Device Component	6	6
Inadequacy of Device Shape and/or Size	6	6
Deflation Problem	6	6
Missing Value Reason	6	6
Loose or Intermittent Connection	5	5
Mechanical Problem	5	5
No Flow	5	5
Disconnection	4	4
Collapse	4	4
Air Leak	4	4
Leak/Splash	4	4
Product Quality Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Unintended Deflation	4	4
Physical Resistance/Sticking	3	3
Insufficient Information	3	3
Difficult to Remove	3	3
Material Puncture/Hole	3	3
Material Separation	3	3
Use of Device Problem	3	3
Detachment Of Device Component	3	3
Difficult to Open or Close	3	3
Failure to Disconnect	3	3
Failure to Deliver	3	3
Structural Problem	2	2
Separation Failure	2	2
Packaging Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Integrity Problem	2	2
Material Twisted/Bent	2	2
Crack	2	2
Disassembly	2	2
Device Alarm System	2	2
Hole In Material	2	2
Nonstandard Device	2	2
No Device Output	1	1
Increase in Pressure	1	1
Material Too Rigid or Stiff	1	1
Improper or Incorrect Procedure or Method	1	1
Suction Problem	1	1
Invalid Sensing	1	1
Shipping Damage or Problem	1	1
Unexpected Therapeutic Results	1	1
Arcing at Paddles	1	1
Complete Blockage	1	1
Failure to Deliver Energy	1	1
Fire	1	1
Fluid Leak	1	1
Melted	1	1
Misconnection	1	1
Moisture Damage	1	1
Mechanical Jam	1	1
Improper Flow or Infusion	1	1
Incorrect Device Or Component Shipped	1	1
No Pressure	1	1
Optical Distortion	1	1
Pressure Problem	1	1
Patient-Device Incompatibility	1	1
Device Markings/Labelling Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Activation, Positioning or SeparationProblem	1	1
Expiration Date Error	1	1
Obstruction of Flow	1	1
Incomplete or Missing Packaging	1	1
Ventilation Problem in Device Environment	1	1
No Apparent Adverse Event	1	1
Patient Device Interaction Problem	1	1
Material Split, Cut or Torn	1	1
Incomplete or Inadequate Connection	1	1
Suction Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	96	96
No Consequences Or Impact To Patient	34	34
Missing Value Reason	31	31
Insufficient Information	21	21
No Clinical Signs, Symptoms or Conditions	19	19
No Patient Involvement	14	14
Low Oxygen Saturation	14	14
Cardiac Arrest	10	10
Death	9	9
No Code Available	9	9
Hypoxia	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Not Applicable	3	3
No Information	2	2
Cerebral Edema	2	2
Loss of consciousness	2	2
Respiratory Arrest	2	2
Low Blood Pressure/ Hypotension	2	2
Vomiting	2	2
Anemia	1	1
Hypoventilation	1	1
Decreased Respiratory Rate	1	1
Burn, Thermal	1	1
Fracture, Arm	1	1
Pneumothorax	1	1
Respiratory Distress	1	1
Seizures	1	1
Dyspnea	1	1
Endocarditis	1	1
Cardiopulmonary Arrest	1	1
Unspecified Tissue Injury	1	1
Asystole	1	1
Cardiovascular Insufficiency	1	1
Foreign Body In Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Sun Med, LLC	II	Jun-09-2018
2	Vyaire Medical	I	Aug-08-2018