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

Model Number VPL-3153B

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

Patient Problem Sprain (2083)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

Review of product records showed that this unit suffered cosmetic damage (what looked to be a fork lift dent about 24" higher than the pallet) to the platform gate during shipping.The dealer was sent a replacement platform gate before installation.Upon incident notification bruno requested a video conference inspection with the distributor at the site.This was attended by the technical service manager, the chief engineer of the vpl product line and the senior member of the dealer training staff.During the onsite video inspection hosted by the distributor's accessibility supervisor, he disclosed that one of their service technicians performed service on the unit after they had notification of the incident.That technician was not part of the video inspection and the host had no knowledge of what was adjusted.During the video inspection a number of tests were performed at the requests of the manufacturer's attendees to ensure that the gate could not be opened unless at the proper location on the bottom landing.The unit performed properly for all the tests run during the inspection.Although the unit seemed to be in good working condition, it was put in a "lock out" mode to prevent use until a more detailed inspection ensured safe operation.In follow up message from the distributor, it was alleged that the magnetic latch on the platform gate would not fully engage without pulling the gate closed manually.He however also noted that the safety switch on the gate was activated even when the gate was not fully closed allowing the unit to move up with the gate in a semi-closed position.The installation manual provided with the unit requires the installer to verify that when the door is open that the unit will not operate in any direction.It appears that this test was not conducted during installation, otherwise the issue would have been found before going into service.In the follow up message, we were informed the technician also noted that the latch at the bottom corner of the platform gate did not latch fully until the unit was elevated several inches up, this likely occurred due to the latch rod at the bottom of the unit not being correctly cut by the installer and left at the original length, thus allowing the gate to be opened if the enough force were applied to overcome the magnetic lock.Apparently, during the repairs, the technician cut the latch rod to the correct shorter length allowing the latch to engage correctly as designed.Along with the addition and removal of a few shims in the hinges, the magnetic lock could function as designed and intended and close consistently without the possibility of opening.These fixes to errors during the installation of the unit provide some insight on why during bruno's inspection, the unit passed all of bruno's tests.The distributor is receiving additional training regarding the installation and troubleshooting of the product line.

Event Description

The event was described to the manufacturer 4th hand.A neighbor heard the user calling out and found the user laying on the garage floor (lower landing) with the platform at the upper landing 28" higher.The user had a mild sprained ankle.The neighbor relayed the information to the user's son who called the distributor.The distributor's service person passed it on to the accessibility manager who reported to bruno.According to the distributor, the neighbor could not remember the condition and state of the unit other than the location of the platform.It is alleged that the unit could operate up and down with the door open, possibly allowing for the user to exit the platform while not on the correct landing.When installed properly according to manufacturer instructions, the unit is not able to move up or down unless the door is closed.Furthermore, the installer is instructed to test this during the installation process in the installation manual provided with the product.

• Brand Name: BRUNO INDEPENDENT LIVING AIDS, INC.
• Type of Device: VERTICAL PLATFORM LIFT
• Manufacturer (Section D): BRUNO INDEPENENT LIVING AIDS, INC.; 1780 executive drive; oconomowoc WI 53066
• Manufacturer (Section G): BRUNO INDEPENDENT LIVING AIDS, INC.; 1780 executive drive; oconomowoc WI 53066 0084
• Manufacturer Contact: william belson iii ; 1780 executive drive; oconomowoc, WI 53066-0084 ; 2629535359
• MDR Report Key: 11289353
• MDR Text Key: 230677228
• Report Number: 2131358-2021-00001
• Device Sequence Number: 1
• Product Code: ING
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K061514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VPL-3153B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR