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

Model Number VPL-3175B

Device Problem Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

Current dealer informed bruno of the incident on 01-05-2022.The current dealer in (b)(6) is not the installing dealer.The current dealer started supporting the unit in (b)(6) 2018.Bruno contacted the dealer on 01-5-2022 and arranged to send the chief engineer for the product line to conduct on-site for inspection.This inspection was delayed at end user's request to later in january.At the site, the chief engineer confirmed with the end user that there were no injuries as a result of this incident.The initial site investigation indicated that the main drive nut was worn to point of failure causing the platform to fall on the safety nut, as intended.The safety switch however did not engaged and thus allowed the unit to ride on safety nut.The safety nut then failed causing the unit to fail.This was the first time this type of nut safety switch engagement failure was observed.It was not possible to do a complete inspection on site.Parts were removed to continue the investigation at the manufacturer's facilities.This capa investigation to determine root cause is being conducted under the oversight of the director of engineering to determine reason(s) that may have prevented the safety switch from being activated.

Event Description

The event was described to the manufacturer third hand when reported on (b)(6)2022.The end user has a vpl-3175b (6ft or 75" travel) unit installed with an unenclosed exterior application that was installed in 2013.On (b)(6) 2021, a friend of the end user's adult daughter was operating the unit, standing on the platform, while it ascended.It was reported that the unit dropped without notice.There was conflicting information if the rider suffered a minor injury.

• Brand Name: BRUNO
• 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: 13460512
• MDR Text Key: 287669815
• Report Number: 2131358-2022-00002
• 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: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: VPL-3175B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 147 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White