TPLC - Total Product Life Cycle

show TPLC since

Device	cardiopulmonary resuscitation aid kit
Regulation Description	Manual emergency ventilator.
Definition	This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product Code	OEV
Regulation Number	868.5915
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inflation Problem	12	12
Component Missing	11	11
Break	11	11
Blocked Connection	10	10
Gas/Air Leak	8	8
Material Split, Cut or Torn	6	8
Material Integrity Problem	5	5
Dent in Material	4	4
Material Puncture/Hole	3	3
Mechanical Problem	3	3
Mechanical Jam	2	2
Material Deformation	2	2
Leak/Splash	2	2
Disconnection	2	2
Inadequate User Interface	2	2
Incomplete or Inadequate Connection	2	2
Product Quality Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Improper Flow or Infusion	1	1
Defective Device	1	1
Misassembled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	51	51
Cardiac Arrest	12	14
Insufficient Information	10	10
Low Oxygen Saturation	7	7
Hypoxia	6	6
Brain Injury	2	2
Respiratory Failure	2	2
Cyanosis	2	2
Respiratory Arrest	2	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Pulmonary Infarction	1	1
Asystole	1	1