TPLC - Total Product Life Cycle

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Device	calculator, pulmonary function data
Regulation Description	Pulmonary-function data calculator.
Product Code	BZC
Regulation Number	868.1880
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	8	8
Detachment of Device or Device Component	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Electrical Shorting	2	2
Break	2	2
Computer Software Problem	2	2
Insufficient Information	2	2
Smoking	2	2
Overheating of Device	2	2
Battery Problem	1	1
Contamination /Decontamination Problem	1	1
Device Dislodged or Dislocated	1	1
Environmental Particulates	1	1
Component Incompatible	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Gas Output Problem	1	1
Material Integrity Problem	1	1
Temperature Problem	1	1
Explosion	1	1
Intermittent Communication Failure	1	1
Use of Device Problem	1	1
Product Quality Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	22	22
Abrasion	4	4
Dyspnea	3	3
Discomfort	2	2
No Patient Involvement	1	1
Convulsion/Seizure	1	1
Laceration(s)	1	1
Dizziness	1	1
Sore Throat	1	1
Loss of consciousness	1	1
Tooth Fracture	1	1
Decreased Respiratory Rate	1	1
Bruise/Contusion	1	1
Headache	1	1
Low Blood Pressure/ Hypotension	1	1
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Vyaire Medical, Inc.	I	May-08-2024