TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	1
AMBU INTERNATIONAL A/S
	SUBSTANTIALLY EQUIVALENT	1
FOREMOUNT ENTERPRISE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2016	91	91
2017	56	56
2018	53	53
2019	46	46
2020	26	26

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Issue	31	31
Break	28	28
Separation Failure	21	21
Device Operates Differently Than Expected	21	21
Device Operational Issue	19	19
Inflation Problem	16	16
Device Damaged Prior to Use	16	16
Difficult to Remove	15	15
Appropriate Term/Code Not Available	14	14
Bag	13	13
Defective Component	12	12
Connection Problem	12	12
Defective Device	11	11
Deflation Problem	9	9
Component Missing	9	9
Tube	8	8
Missing Value Reason	8	8
Fitting Problem	8	8
Valve(s)	7	7
Detachment Of Device Component	6	6
Disconnection	6	6
Material Deformation	6	6
Air Leak	6	6
Activation, Positioning or SeparationProblem	6	6
Material Separation	5	5
Crack	5	5
Device Dislodged or Dislocated	5	5
Material Integrity Problem	5	5
Inadequacy of Device Shape and/or Size	5	5
Sticking	5	5
Loose or Intermittent Connection	5	5
Kinked	4	4
Leak/Splash	4	4
Product Quality Problem	4	4
Failure to Disconnect	4	4
Manufacturing, Packaging or Shipping Problem	4	4
No Flow	4	4
Mechanical Problem	4	4
Collapse	3	3
Detachment of Device or Device Component	3	3
Torn Material	3	3
Insufficient Information	3	3
Port	3	3
Device Alarm System	2	2
Device Markings/Labelling Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Hole In Material	2	2
Packaging Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Difficult to Open or Close	2	2
Difficult to Open or Remove Packaging Material	2	2
Disassembly	2	2
Incomplete or Missing Packaging	2	2
Failure to Deliver	2	2
Melted	2	2
Bent	2	2
Seal	1	1
Arcing at Paddles	1	1
Valve, Flap	1	1
Heads	1	1
Ring	1	1
Nonstandard Device	1	1
Material Puncture/Hole	1	1
Complete Blockage	1	1
Structural Problem	1	1
Expiration Date Error	1	1
Fire	1	1
Shipping Damage or Problem	1	1
Patient-Device Incompatibility	1	1
No Apparent Adverse Event	1	1
Gas Leak	1	1
Improper Flow or Infusion	1	1
Mechanical Jam	1	1
Patient Device Interaction Problem	1	1
Material Split, Cut or Torn	1	1
No Pressure	1	1
Optical Distortion	1	1
Pressure Problem	1	1
Ventilation Problem in Device Environment	1	1
Device Subassembly	1	1
Incomplete or Inadequate Connection	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Incorrect Device Or Component Shipped	1	1
Device Displays Incorrect Message	1	1
Invalid Sensing	1	1
Failure To Adhere Or Bond	1	1
Restricted Flow rate	1	1
Connector	1	1
Label	1	1
Improper or Incorrect Procedure or Method	1	1
Misconnection	1	1
Moisture Damage	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	147	147
Missing Value Reason	54	54
No Consequences Or Impact To Patient	40	40
Not Applicable	25	25
No Patient Involvement	18	18
No Information	14	14
Death	12	12
No Code Available	10	10
Low Oxygen Saturation	7	7
Hypoxia	5	5
Cardiac Arrest	3	3
Low Blood Pressure/ Hypotension	2	2
Hypoventilation	1	1
Cardiopulmonary Arrest	1	1
Dyspnea	1	1
Fracture, Arm	1	1
Insufficient Information	1	1
Respiratory Distress	1	1
Seizures	1	1
Brain Injury	1	1
Burn, Thermal	1	1

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