TPLC - Total Product Life Cycle

• Device: elevator, wheelchair, portable
• Definition: A motorized lift device that is not permanently mounted in one location and that is intended for medical purposes to provide a means to move a person with impaired mobility, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).
• Product Code: ING
• Regulation Number: 890.3930
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BELLA ELEVATOR, LLC
	SUBSTANTIALLY EQUIVALENT	1
HARMAR SUMMIT LLC
	SUBSTANTIALLY EQUIVALENT	1
SANO TRANSPORTGERATE GMBH
	SUBSTANTIALLY EQUIVALENT	1
THYSSENKRUPP CETECO SRL
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2017	2	2
2018	7	7
2019	4	4
2020	7	7
2021	6	6
2022	3	3
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	12	12
Adverse Event Without Identified Device or Use Problem	7	7
Insufficient Information	4	4
Labelling, Instructions for Use or Training Problem	2	2
Device Fell	2	2
Improper or Incorrect Procedure or Method	1	1
Unintended System Motion	1	1
Therapeutic or Diagnostic Output Failure	1	1
Break	1	1
Ambient Noise Problem	1	1
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Bone Fracture(s)	8	8
Bruise/Contusion	6	6
Abrasion	3	3
Head Injury	3	3
Laceration(s)	3	3
Injury	3	3
Fall	3	3
Insufficient Information	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Death	2	2
Contusion	1	1
Pneumothorax	1	1
Sprain	1	1
Concussion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	The Braun Corporation	II	Sep-22-2010