TPLC - Total Product Life Cycle

• Device: resuscitator, manual, non self-inflating
• Definition: A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.
• Product Code: NHK
• Regulation Number: 868.5905
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2018	3	3
2019	6	6
2020	1	1
2021	7	7
2022	7	7
2023	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Device	5	5
Physical Resistance/Sticking	5	5
Crack	3	3
Break	2	2
Improper or Incorrect Procedure or Method	2	2
Detachment of Device or Device Component	2	2
Component Missing	2	2
Material Integrity Problem	2	2
Pressure Problem	1	1
Torn Material	1	1
No Apparent Adverse Event	1	1
Patient Device Interaction Problem	1	1
Incomplete or Missing Packaging	1	1
Device Dislodged or Dislocated	1	1
Material Perforation	1	1
Device Damaged Prior to Use	1	1
Detachment Of Device Component	1	1
Disconnection	1	1
Hole In Material	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Decrease in Pressure	1	1
Material Rupture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9	9
Insufficient Information	4	4
No Consequences Or Impact To Patient	3	3
No Known Impact Or Consequence To Patient	3	3
Decreased Respiratory Rate	2	2
Bradycardia	2	2
No Code Available	1	1
Airway Obstruction	1	1
Low Oxygen Saturation	1	1
Respiratory Failure	1	1
Bruise/Contusion	1	1
Missing Value Reason	1	1