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

Model Number VPL-3210B

Device Problem Break (1069)

Patient Problem Bruise/Contusion (1754)

Event Date 07/12/2021

Event Type  Injury  

Manufacturer Narrative

Bruno chief engineer of vpl product line (b)(4), met with authorized bruno dealer (b)(4) president (b)(4) at the dealer's office at 7:30 am on (b)(6) 2021.They traveled to the customer's home in (b)(6) arriving at 8:30 am bruno engineer observed the vpl able to power teh motor but with the platform located tight against the ground.The motor was able to run so the acme nut safety switch was most likely not engaged.They meet with the homeowner (b)(6) who told them he was riding up on the vpl when it started to slow before it dropped 11 feet.(this observation is beyond the lift of the installed model and discovered incorrect during investigation.) he was standing on the platform.(b)(6) stated he injured his left hand, left elbow, and right knee.(b)(6) required medical evaluation for his injuries which were all bruising with noticeable coloring since the incident.Bruno engineer measured the lifting height of the unit at 104.5 inches (8.75 feet).Brass shavings were found at 63" which means the real free fall was approximately 5 feet.Pictures of the unit during our inspection were taken with some added to the end of this report.Bruno engineer assisted in the removal of the front panels and platform from the tower to gain access to the drive area of the lift.(b)(6) told me that he found several thin pieces of brass shavings around head level (5 feet) off the platform which i confirmed by finding more which i collected.He showed me a picture which confirmed the shavings from the acme nut.I found that the acme drive nut (upper one) was tight against the safety nut (lower one), but the nut safety switch was not activated.It was then observed that the bracket attached to the safety nut which is used to activate the safety switch was loose.The hardware (one bolt, lock washer, and nut) was loose which allowed the bracket to drop making it unable to compress the safety switch when the top acme dropped unto the safety nut.Bruno engineer also found that the hardware (2 bolts, lock washers, and nuts) holding the nut safety switch bracket was loose.The top acme nut failed under normal wear over time based on environmental conditions and lack of preventative maintenance.The acme joint pins were observed in correct orientation and were not a contributing factor.The dealer (b)(6) told bruno engineer that the last maintenance call was january 2020.The customer had a preventative maintenance contract on the unit in the past but was no longer under contract.The homeowner (b)(6) told bruno engineer that the unit started to slow down just before it dropped.This fact indicates that the motor was having to work through something on the acme screw.Assumed that at some point the acme nut failed and dropped unto the safety nut but because the safety switch was not activated the unit could run on the safety nut.Bruno engineer explained to customer (b)(6) that the root cause was undetermined at this point in time but with all the rust and lack of preventative maintenance these types of lifts really need to be maintained.Customer seemed satisfied with the explanation.Bruno engineer was engaging the customer william during the investigation and repair which helped during the day.

Event Description

The customer called the dealer on (b)(6) 2021 and reported his platform dropped on model vpl-3210b sn (b)(4).The dealer traveled to the site on the same day.Stated that he suspected that the acme nuts failed resulting in the platform dropping when the customer was riding it upward.The dealer relayed the initial report to bruno technical service department on (b)(6) 2021 and that the customer has a bruise on his left hand palm.The platform was damaged and the screw has a lot of brass shavings in the threads.The dealer stated that the last maintenance service call was jan 2020.

• 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 (Section G): BRUNO INDEPENDENT LIVING AIDS, INC.; 1780 executive drive; oconomowoc WI 53066
• Manufacturer Contact: william belson iii ; 1780 executive drive; oconomowoc, WI 53066 ; 2629535359
• MDR Report Key: 12305345
• MDR Text Key: 266027381
• Report Number: 2131358-2021-00003
• 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: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VPL-3210B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR