BRUNO INDEPENDENT LIVING AIDS, INC.
Report
- Report Number
- 2131358-2025-00002
- Event Type
- Injury
- Date Received
- December 31, 2025
- Date of Event
- September 6, 2025
- Report Date
- December 23, 2025
- Manufacturer
- BRUNO INDEPENDENT LIVING AIDS, INC.
- Product Code
- PCE
- PMA / PMN Number
- K061514
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 501
Narratives
BELOW IS THE INVESTIGATION TRIP NOTES FROM JOINT INVESTIGATION WITH BRUNO REGULATORY AND TEST ENGINEERING MANAGER (B)(4) ALONG WITH THE EXPERT HIRED BY THE PATIENT AND ELEVATOR CONTRACTORS. REPRESENTITIVES OF THE ORIGINAL INDEPENDANT CONTRACTOR WHO PURCHASED THE UNIT FROM BRUNO AND THEIR SUB-CONTRACTOR WHO INSTALLED THE UNIT WERE NOT PRESENT. SUBJECT: TRIP NOTES OF INVESTIGATION OF THE VPL -3210B IN (B)(6) (CASE (B)(4) ON (B)(6) 2025 (TRIP #2). 1. PARTIES FROM (B)(6) WERE REPRESENTED. 2. PARTIES FROM TRAVELERS WERE REPRESENTED. 3. PARTIES FROM BRUNO WERE REPRESENTED. 4. PARTIES FROM ACCESS ELEVATOR & LIFT WERE REPRESENTED. 5. PARTIES FROM 101MOBILITY WERE REPRESENTED. 6. HOMEOWNER (B)(6) WAS HOME DURING THE INSPECTION. 7. A SIGN IN LOG WAS CREATED BY MBBB AND WILL BE SHARED. 8. EVERYONE AGREED TO GET STARTED WITH THE INSPECTION AT 8:15 AM ON (B)(6) 2025 EXCEPT FOR 101 MOBILITY WHO WAS SCHEDULED TO START AT 9 AM WHICH ALLOWED US TIME TO LOOK AT THE UNIT BEFORE TRYING TO FIX ANYTHING. 9. NOTHING WAS DISTURBED SINCE OUR FIRST VISIT ON (B)(6) 2025. 10. WE FIRST OPENED THE PANEL TO THE EMI WIRING AT THE TOP LANDING GATE. A. PICTURES SHOWING THE WIRING TO THE TOP LANDING GATE WAS NOT ATTACHED TO THE DOOR LOCK SWITCH AND WAS BYPASSED (BROWN AND GREEN WIRE CRIMPED TOGETHER WITH BRUNO BUTT SPLICE). THE ORIGINAL BRUNO BUTT SPLICE WAS USED FOR THE BYPASS SHOWING THAT THIS WAS DONE DURING THE ORIGINAL TOP LANDING GATE INSTALLATION. B. PHOTO #1 C. PHOTO #2 D. SCHEMATIC UNIT PHOTO #3 11. THE TOP GATE/DOOR LOCK SWITCH WAS TESTED AND FOUND TO BE WORKING CORRECTLY. 12. THE "JUMPER" TYPE WIRING WAS REMOVED AND SAVED IN A PLASTIC BAG. 13. WE THEN PROCEEDED TO CORRECTLY WIRE THE TOP LANDING GATE. THIS WAS COMPLETED AND SUPERVISED BY THE PLAINTIFF'S EXPERT (BEFORE SPEAKING TO HIS COUNSEL). IT WAS THE PLAINTIFF'S EXPERT THAT STATED THAT THE SWITCH WAS JUMPED DURING THE ORIGINAL INSTALLATION BECAUSE OF THE ORIGINAL BRUNO BUTT SPLICES USED TO JUMPER THE WIRING. HE ALSO STATED TO THE PLAINTIFF THAT HER ACCIDENT WOULD NOT HAVE HAPPENED IF THE WIRING WAS CORRECT AT TIME OF INSTALLATION. 14. AFTER CORRECTLY WIRING THE TOP LANDING GATE, WE TESTED THE PLATFORM AND CONFIRMED THE PLATFORM WOULD NOT TRAVEL MORE THAN 2" IN THE DOWN DIRECTION AWAY FROM THE TOP LANDING. 15. WE THEN WENT BACK AND ADJUSTED THE UPPER LIMIT, GATE ENABLE SWITCH, AND GATE ACTUATOR BRACKET TO WORK WITH THE PLAINTIFF (NORMAL WEIGHT AND LOCATION ON THE PLATFORM). THESE ADJUSTMENTS TOOK A FAIR AMOUNT OF TIME BUT ARE NORMAL DURING THE INSTALLATION PROCESS. IT IS POSSIBLE THE INSTALLING DEALER WAS LOOKING TO SAVE TIME WITH THESE ADJUSTMENTS THEREFORE BYPASSED THE SAFETY FEATURES BUILT INTO THE UNIT. 16. THERE IS AN INSPECTION FRAME MOUNTED TO THE PLATFORM REAR WALL BUT THERE IS NO INSPECTION DOCUMENTATION IN THE FRAME. A. PHOTO OF MA STATE ELEVATOR INSPECTION CERTIFICATE FRAME 17. IT WAS NOT CLEAR IF THE UNIT WAS EVER INSPECTED BY THE AHJ. 18. AFTER ALL REPAIRS WERE COMPLETED, WE CONDUCTED AN INSPECTION WITH THE USE OF THE MCP CHECK LIST (SEE ATTACHED). 19. ITEMS TO NOTE ON THE CHECK LIST (DATED (B)(6) 2025): A. THE GREASE ON THE ACME SCREW IS BLACK AND VERY THIN. IT IS LIKELY THE GREASE IS ORIGINAL AND NEVER BEEN SERVICED. B. THERE IS GREASE ON THE VERTICAL TUBES OF THE TOWER WHICH WAS ADDED BY ACCESS ELEVATOR & LIFT DURING A SERVICE CALL. THIS WAS ADDED TO HELP THE ACME SCREW STABILIZER SLIDE FREELY ON THE VERTICAL TUBES WHILE THE PLATFORM WENT UP AND DOWN. THIS CORRECTED A PROBLEM WITH THE ACME SCREW STABILIZED HANGING UP AND DROPPING DOWN ON THE CARRIAGE, CAUSE A LOAD NOISE INSIDE THE TOWER. C. THERE ARE BOTTOM SAFETY PANS ON THE PLATFORM, BUT THEY WERE BYPASSED AND NOT OPERATIONAL. THIS IS NOT A SAFETY ISSUE BECAUSE THE UNIT IS INSIDE A HOISTWAY. D. THE FRONT WALL ON THE PLATFORM IS LOOSE ON THE CORNER NEAR THE GATE ACTUATOR BRACKET. THE PLAINTIFF SHOWED US HOW SHE USES THE LIFT AND PUSHES AGAINST THE WALL EACH TIME SHE GETS IN AND OUT OF THE LIFT. A FEW SUGGESTIONS WERE MADE BY THE PLAINTIFFS EXPERT, WHICH WILL BE FOLLOWED UP BY THE PLAINTIFF (FUTURE SERVICE CALL). 20. THE INSPECTION/REPAIR ENDED AT APPROXIMATELY 1:30 PM ON (B)(6) 2025. BEST REGARDS, (B)(4), P.E. REGULATORY AND TEST ENGINEERING MANAGER INVESTIGATION CONTINUED WITH THE ORIGINAL INDEPENDANT CONTRACTOR WHO PURCHASED THE UNIT. THIS TOOK OVER 6 WEEKS TO ACCESS FILES SINCE ASSESTS HAVE BEEN SOLD SINCE 2022. ALL RECORDS WERE STORED REMOTELY. INVESTIGATION DETERMINED: 1) ORIGINAL INDEPENDENT CONTRATOR (DEALER) HAD BEEN TRAINED AT BRUNO BUT DID NOT HAVE A MA. ELEVATOR'S LICENSE, THUS COULD NOT PULL PERMITS FOR AND PERFORM THE INSTALLATION. THEY SUBCONTRACTED THE INSTALLATION TO A LICENSED ELEVTOR CONTRATOR FOR THIS INSTALLATION.THIS SUB-CONTRACTOR WAS (B)(4) OF RESIDENTIAL ELEVATOR AND LIFT IN (B)(4). WHO STILL HOLDS A MA ELEVATOR CONTRACTOR LICENSE #(B)(4). COMPANY INFORMATION ATTACHED. 2) BRUNO COMPLAINT FILE CASE NOTES SHOW NO SERVICE HISTORY FOR THIS UNIT BY ORIGINAL INDEPENDENT CONTRACTOR. 3) NO RECORDS FROM THE3RD DEALER WHO SERVICED THE UNIT SHOW THAT THEY EVER TESTED THE TOP LANDING GATE SATETY CIRCUITRY. 4) ATTACHED IS THE VERTICLA PLATFORM LIFT INSPECTION AND TESTING CHECKLIST PERFORMED AT THE END OF THE INSPECTION. 5) CONCLUSION IS THAT THE UPPER GATE SAFETY CIRCUIT HAD BEEN BYPASSED SINCE THE INSTALLATION. THIS WOULD NOT HAVE ALLOWED THE PLATFORM TO MOVE AWAY FROM THE UPPER LANDING. THIS BYPASS OF THE SAFETY CIRCUIT SHOULD HAVE BEEN CAUGHT AT ANY OF THE INSPECTIONS.
MANUFACTURER WAS NOTIFIED OF AN INCIDENT ON OCTOBER 8TH BY EMAIL SENT AFTER NORMAL BUSINESS HOURS FROM PATIENT'S ATTORNEY. THIS EMAIL HAD NO DETAILS OF THE INCIDENT. IT ONLY MENTIONED THAT THE UNIT, (B)(4), WAS TO BE REPAIRED IN 39 HOURS ON (B)(6) AT 9:00AM EASTERN, AND IT WOULD BE THE ONLY OPPORTUNITY TO INSPECT THE UNIT AND UNDERSTAND THE REPAIRS NEEDED. BRUNO SENT ITS DIRECTOR OF ENGINEERING [(B)(4)] FROM WISCONSIN HEADQUARTERS TO ATTEND AND INVESTIGATE. AT 9:05AM ON THE MORNING OF (B)(6), PATIENT ANSWERED DOOR AND INFORMED MR. (B)(4) THAT THE INSPECTION AND REPAIRS HAD BEEN CANCELLED THE NIGHT BEFORE. SHE WOULD NOT SHARE ANY DETAILS REGARDING THE INCIDENT NOR ALLOW MR. (B)(4) TO VIEW THE UNIT. DURING THE RESCHEDULED INSPECTION ON FRIDAY, (B)(6), DETAILS OF THE INCIDENT WERE FINALLY SHARED: 1. THE LIFT IS LOCATED IN A 2-STORY GARAGE. PATIENT EXPLAINED SHE WAS ATTEMPTING TO ENTER THE PLATFORM FROM THE UPPER LANDING (2ND FLOOR) GOING FORWARD ON HER WHEELCHAIR AND FELL TO THE LOWER LANDING, A DISTANCE OF 102 INCHES. 2. IT WAS EXPLAINED THAT A VISITING FAMILY MEMBER USED THE LIFT TO LEAVE THE HOME AND RAN THE PLATFORM TO THE LOWER LANDING. NORMALLY THE PLATFORM WOULD BE AT THE SAME LANDING AS PATIENT, SINCE SHE IS THE SINGLE USER IN THE HOME. HOWEVER, IN THIS CASE, SHE WENT TO USE THE VPL FROM THE UPPER LANDING, THE GATE PULLED OPEN, SHE PROCEEDED TO ENTER THE PLATFORM BUT DIDN'T NOTICE THE PLATFORM WAS NOT THERE AND FELL. 3. THERE IS VERY GOOD LIGHTING IN THE AREA, BUT SHE EXPLAINED IT WAS DARK AT THE TIME SHE ENTERED THE PLATFORM ON (B)(6) (ASSUMING THE LIGHTS WERE TURNED OFF AT THE TIME). 4. IT WAS EXPLAINED THAT THE PATIENT, MS. (B)(6), SUFFERED SEVERAL INJURIES AND WAS HOSPITALIZED. THE INVESTIGATION WAS FOCUSED ON THE REASON THE UPPER LANDING GATE WAS ABLE TO OPEN WITH THE PLATFORM FURTHER THAN THE 2 INCHES FROM THE LANDING. THE UNIT IS DESIGNED, CONSISTENT WITH APPLICABLE CODE[MB1.1], SUCH THAT THE GATE IS NOT ALLOWED TO OPEN IF IT IS NOT WITHIN 2 INCHES OF THE LANDING. MANUFACTURER WAS NOTIFIED OF AN INCIDENT ON OCTOBER 8TH BY EMAIL SENT AFTER NORMAL BUSINESS HOURS FROM PATIENT'S ATTORNEY (ATTACHMENT 1). THIS EMAIL HAD NO DETAILS OF THE INCIDENT. IT ONLY MENTIONED THAT THE UNIT, (B)(4), WAS TO BE REPAIRED IN 39 HOURS ON (B)(6) AT 9:00AM EASTERN, AND IT WOULD BE THE ONLY OPPORTUNITY TO INSPECT THE UNIT AND UNDERSTAND THE REPAIRS NEEDED. BRUNO SENT ITS DIRECTOR OF ENGINEERING [(B)(6)] FROM WISCONSIN HEADQUARTERS TO ATTEND AND INVESTIGATE. AT 9:05AM ON THE MORNING OF (B)(6), PATIENT ANSWERED DOOR AND INFORMED MR. (B)(4) THAT THE INSPECTION AND REPAIRS HAD BEEN CANCELLED THE NIGHT BEFORE. SHE WOULD NOT SHARE ANY DETAILS REGARDING THE INCIDENT NOR ALLOW MR. (B)(4) TO VIEW THE UNIT. DURING THE RESCHEDULED INSPECTION ON FRIDAY, (B)(6), DETAILS OF THE INCIDENT WERE FINALLY SHARED: 1. THE LIFT IS LOCATED IN A 2-STORY GARAGE. PATIENT EXPLAINED SHE WAS ATTEMPTING TO ENTER THE PLATFORM FROM THE UPPER LANDING (2ND FLOOR) GOING FORWARD ON HER WHEELCHAIR AND FELL TO THE LOWER LANDING, A DISTANCE OF 102 INCHES. 2. IT WAS EXPLAINED THAT A VISITING FAMILY MEMBER USED THE LIFT TO LEAVE THE HOME AND RAN THE PLATFORM TO THE LOWER LANDING. NORMALLY THE PLATFORM WOULD BE AT THE SAME LANDING AS PATIENT, SINCE SHE IS THE SINGLE USER IN THE HOME. HOWEVER, IN THIS CASE, SHE WENT TO USE THE VPL FROM THE UPPER LANDING, THE GATE PULLED OPEN, SHE PROCEEDED TO ENTER THE PLATFORM BUT DIDN'T NOTICE THE PLATFORM WAS NOT THERE AND FELL. 3. THERE IS VERY GOOD LIGHTING IN THE AREA, BUT SHE EXPLAINED IT WAS DARK AT THE TIME SHE ENTERED THE PLATFORM ON (B)(6) (ASSUMING THE LIGHTS WERE TURNED OFF AT THE TIME). 4. IT WAS EXPLAINED THAT THE PATIENT, MS. (B)(6), SUFFERED SEVERAL INJURIES AND WAS HOSPITALIZED. THE INVESTIGATION WAS FOCUSED ON THE REASON THE UPPER LANDING GATE WAS ABLE TO OPEN WITH THE PLATFORM FURTHER THAN THE 2 INCHES FROM THE LANDING. THE UNIT IS DESIGNED, CONSISTENT WITH APPLICABLE CODE[MB1.1], SUCH THAT THE GATE IS NOT ALLOWED TO OPEN IF IT IS NOT WITHIN 2 INCHES OF THE LANDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2708446 | BRUNO INDEPENDENT LIVING AIDS, INC. | VERTICAL PLATFORM LIFT, PRODUCT CODE: PCE | PCE | BRUNO INDEPENDENT LIVING AIDS, INC. | VPL-3153B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Required Intervention| H |