TPLC - Total Product Life Cycle

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Device	regulator, pressure, gas cylinder
Regulation Description	Pressure regulator.
Product Code	CAN
Regulation Number	868.2700
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas Output Problem	27	33
Fire	6	6
Gas/Air Leak	6	6
No Flow	4	4
Insufficient Information	3	3
Explosion	3	3
Defective Component	2	2
Misassembly by Users	2	2
Overheating of Device	2	2
Improper or Incorrect Procedure or Method	2	2
Output Problem	1	1
Defective Device	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
High Readings	1	1
Key or Button Unresponsive/not Working	1	1
Use of Device Problem	1	1
Material Twisted/Bent	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Incorrect Measurement	1	1
Device Emits Odor	1	1
Detachment of Device or Device Component	1	1
Device Contamination with Chemical or Other Material	1	1
No Apparent Adverse Event	1	1
Fracture	1	1
Medical Gas Supply Problem	1	1
Appropriate Term/Code Not Available	1	1
Failure to Cycle	1	1
Nonstandard Device	1	1
Connection Problem	1	1
Inaccurate Information	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	55	61
Insufficient Information	22	22
Low Oxygen Saturation	8	8
Partial thickness (Second Degree) Burn	3	3
Full thickness (Third Degree) Burn	3	3
Superficial (First Degree) Burn	2	2
Cardiac Arrest	2	2
Burn(s)	2	2
Dyspnea	1	1
Bradycardia	1	1
Cough	1	1
Convulsion/Seizure	1	1
Loss of consciousness	1	1
Low Blood Pressure/ Hypotension	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Western/Scott Fetzer Company	II	Apr-12-2023
2	Western/Scott Fetzer Company	II	Nov-19-2021