MAUDE Adverse Event Report: BRUNO INDEPENDENT LIVING AIDS, INC. BRUNO INDEPENDENT LIVING AIDS, INC.; VERTICAL PLATFORM LIFT

Model Number VPL-3210B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Fall (1848)

Event Date 12/27/2018

Event Type  Death  

Event Description

Woman was in her wheelchair and riding the lift from the bottom landing.Family member was raising lift from top landing control.She fell out of her wheelchair and was pinned between the hoistway wall and lift in the area of the top landing sill.The person raising the lift continued to raise platform.

• Brand Name: BRUNO INDEPENDENT LIVING AIDS, INC.
• Type of Device: VERTICAL PLATFORM LIFT
• Manufacturer (Section D): BRUNO INDEPENDENT LIVING AIDS, INC.; 1780 executive drive; oconomowoc WI 53066
• Manufacturer Contact: william belson iii ; 1780 executive drive; oconomowoc, WI 53066 ; 2625674990
• MDR Report Key: 10660072
• MDR Text Key: 211014994
• Report Number: 2131358-2019-00001
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: VPL-3210B
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 10/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 26 YR