TPLC - Total Product Life Cycle

• Device: spirometer, diagnostic
• Regulation Description: Diagnostic spirometer.
• Product Code: BZG
• Regulation Number: 868.1840
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CAREFUSION
	SUBSTANTIALLY EQUIVALENT	1
ERESEARCH TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	1
FIM MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
GANSHORN MEDIZIN ELECTRONIC GMBH
	SUBSTANTIALLY EQUIVALENT	1
1.  K160116  SpiroScout
HILL-ROM, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL RESPIRATORY DEVICES S.L.
	SUBSTANTIALLY EQUIVALENT	1
MEDIKRO OY
	SUBSTANTIALLY EQUIVALENT	2
MEDISOFT S.A.
	SUBSTANTIALLY EQUIVALENT	1
MONITORED THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
NDD MEDIZITECHNIK AG
	SUBSTANTIALLY EQUIVALENT	1
PULMONE ADVANCED MEDICAL DEVICES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PULMONX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SDI DIAGNOSTICS, INC
	SUBSTANTIALLY EQUIVALENT	1
VITALOGRAPH IRELAND LTD.
	SUBSTANTIALLY EQUIVALENT	2
VITALOGRAPH(IRELAND) LTD.
	SUBSTANTIALLY EQUIVALENT	3
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	1	1
2016	1	1
2017	1	1
2018	1	1
2019	1	1
2020	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Connector	1	1
Cover	1	1
Housing	1	1
Premature Discharge of Battery	1	1
Product Quality Problem	1	1
Unable to Obtain Readings	1	1
Defective Component	1	1
Device Sensing Problem	1	1
Electrical Shorting	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Cable, Electrical	1	1
Break	1	1
Failure to Charge	1	1
Crack	1	1
Device Emits Odor	1	1
Failure to Power Up	1	1
Smoking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	4	4
No Patient Involvement	2	2
No Clinical Signs, Symptoms or Conditions	1	1
Dyspnea	1	1
No Consequences Or Impact To Patient	1	1