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

Model Number VPL-3175

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Injury (2348)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

Sent chief engineer for the product line to inspect unit in field, found that the accident site condition had been compromised since the original accident condition.Discovery showed that the safety system had been bypassed allowing the lift to run.Backup failure caused the unit to drop.Based on discussions at site with dealer, suspect this bypass of safety system occurred when dealer serviced the unit in april 2017 (10 months before the accident).After locking out the equipment, access to the safety circuit is only gained by using tools to remove large tower access panels.Then the drive nut safety circuitry was bypassed with a harness.Maintenance of the equipment and the circuitry is gone over in detail during required dealer training.The ability to bypass the drive safety circuitry is required in the event of failure to allow first responders to use the safety nut for a one way trip safely lower the platform to lower landing and then "lock out" system until parts can be replaced.

Event Description

Unit platform dropped and person injured.The platform dropped due to the failure of the drive nut and safety nut.Unless tampered with, if the drive nut fails the safety switch is engaged to prevent the unit from running while the platform securely rests on the safety nut.

• Brand Name: BRUNO
• 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 ; 2629535359
• MDR Report Key: 10660082
• MDR Text Key: 231256481
• Report Number: 2131358-2018-00002
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/19/2018

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-3175
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 10/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2015
• 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: 60 YR