BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRUNO

    MDR report key: 16668721 · Received April 3, 2023

    Report

    Report Number
    2131358-2023-00001
    Event Type
    Death
    Date Received
    April 3, 2023
    Date of Event
    August 23, 2021
    Report Date
    March 28, 2023
    Manufacturer
    BRUNO INDEPENDENT LIVING AIDS, INC.
    Product Code
    PCE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION WAS COMPILED FROM THE MARCH 20TH DISCUSSIONS WITH THE INDEPENDENT DEALER OWNERSHIP WHO INSTALLED THE MODEL VPL-3214B, SN (B)(4) UNIT. IT IS ALSO AUGMENTED BY THE THOROUGH SEARCHES OF COMPLAINT FILE CASE DATA, DEVICE HISTORY FILES AS WELL AS PUBLIC INFORMATION. UNIT SN (B)(4) WAS BUILT, TESTED ON JULY 13TH, AND THEN PACKAGED AND SHIPPED ON JULY 14TH, 2021, FROM BRUNO INDEPENDENT LIVING AIDS. IT IS A 14FT TRAVEL UNIT FOR AN ENCLOSED SHAFT WAY, 48" X 36" 90 DEGREE PLATFORM, WITH THREE LANDING LOCATIONS (LOWER, MID-LANDING AND UPPER). THE DEALER ORDERED A WAUPACA EMI III (DOOR ELECTRIC MECHANICAL INTERLOCK), RIGHT HAND OPENING FOR UPPER LANDING FROM BRUNO. ALL THE DOORS AND OTHER INTERLOCKS WERE SUPPLIED BY THE INSTALLERS, THOUGH THE LANDING CONTROLS AND TIMERS WERE PART OF THE BRUNO SUPPLIED PRODUCT. IT WAS SHIPPED TO ACCESS ABILITIES IN OAKVILLE ONTARIO. THE UNIT WAS IN THE PROCESS OF INSTALLATION AT THE HOME OF THE PATIENT'S DAUGHTER WHERE SHE HAD MOVED. THE PATIENT WAS USING A WALKER TO ASSIST WITH MOBILITY AND REPORTEDLY WAS SUFFERING FROM DEMENTIA. ACCORDING TO THE ACCESS ABILITIES OWNERSHIP, THE UNIT WAS AN URGENT INSTALL AND THE FAMILY MEMBERS WERE APPLYING INTENSE PRESSURE TO GET THE UNIT INSTALLED AND OPERATING FOR THEIR MOTHER (PATIENT). THE DEALER STATED THAT THE UNIT WAS INSTALLED, AND THE PATIENT WAS TRAINED TO USE THE UNIT. SHORTLY AFTER INSTALLATION, THE DEALER STATED THEY RECEIVED A SERVICE CALL FROM THE PATIENT'S DAUGHTER, AND IT WAS FOUND THAT THE PATIENT COULD NOT OPERATE THE MECHANICAL LANDING INTERLOCK ON THE MID LANDING DOOR (BRAND AND STYLE NOT KNOWN TO BRUNO AS BRUNO DID NOT SUPPLY). THE CONTROLS WOULD NOT ALLOW THE UNIT TO OPERATE IF THE MID-LANDING POSITION INTERLOCK WASN'T SENDING THE CORRECT SIGNAL (AS DESIGNED TO FAIL SAFE). THE ACCESS ABILITIES INSTALLATION TECHNICIAN BYPASSED THE MID-LANDING INTERLOCK AND WAS ASSURED BY THE FAMILY THAT THIS WOULD NOT BE USED WITHOUT SUPERVISION. THIS IS A POSITION THAT BRUNO HAS NEVER CONDONED, AND DEALER TRAINING EMPHASIZES THAT THE UNIT SHOULD HAVE BEEN LOCKED-OUT/TAGGED-OUT WITH DOOR SECURED UNTIL THE CONTROL HARNESS ISSUE WAS TROUBLESHOT AND FIXED OR WAS REPLACED. IT IS NOT CURRENTLY CLEAR WHY THE PLATFORM WAS MOVED ON (B)(6) 2021, AND WHERE THE ACCESS ABILITIES TECHNICIAN WAS WORKING ON A SEPARATE HANDRAIL INSTALLATION WHEN THE PATIENT APPARENTLY OPENED THE MID-LANDING DOOR AND STEPPED INTO THE SHAFT-WAY FALLING THE APPROXIMATE 3 FT TO THE LOWER LANDING SUFFERING INJURIES. SHE WAS TAKEN TO A LOCAL HOSPITAL AND AT THIS POINT, THE EXTENT OF THE INJURIES CONTRIBUTING TO HER DEATH IS NOT CLEAR. BRUNO HAS NO KNOWLEDGE IF THE HOSPITAL REPORTED THE INJURY. THE FIRST NOTICE BRUNO HAD OF THE INCIDENT WAS THE RECEIPT OF THE VERY SHORT, INCOMPLETE LETTER FROM (B)(6) LAW FIRM WITH THE MISLEADING UNIT IDENTIFICATION. AN ACCESS ABILITIES' TECHNICIAN HAD ATTENDED AND PASSED BRUNO TRAINING IN JULY 2017 AND RE-CERTIFICATION TRAINING IN OCTOBER 2022. THIS INCLUDED THE RESPONSIBILITIES TO TIMELY INFORM BRUNO OF ANY ACCIDENT OR ADVERSE EVENT OCCURRING WITH VPL PRODUCTS. THE FIRST AND ONLY COMPLAINT CASE OPENED ON THIS SERIAL NUMBER WAS ON (B)(6) 2021, WHEN AN INDIVIDUAL FROM ACCESS ABILITIES CALLED AND TROUBLESHOT THE CONTROL CIRCUIT TO CORRECT ANY ISSUES. AT NO TIME WAS BRUNO INFORMED BY ACCESS ABILITIES OF: 1) OF ANY ACCIDENT 2) OF ANY BYPASSING THE MID-LANDING INTERLOCK SAFETIES. DESPITE DOZENS OF CONTACTS IN THE TIME SINCE (B)(6) 2021, UNTIL RECEIVING THE LETTER FROM (B)(6) LAW FIRM THERE WAS NO INFORMATION ON AN ACCIDENT REPORTED FROM ACCESS ABILITIES TO BRUNO. DURING THE MARCH 20TH, 2023, CONVERSATION WITH ACCESS ABILITIES, THEY INFORMED BRUNO THAT THEY WOULD PROVIDE COPIES OF ALL SERVICE HISTORY RECORDS THOUGH THEY HAVE NOT PRODUCED THEM TO DATE. THEY ALSO INFORMED BRUNO THAT AN INSPECTION OF THE UNIT OCCURRED IN 2023 AND ALL OF SN (B)(4) SYSTEMS, SAFETIES AND INTERLOCKS WERE FUNCTIONING CORRECTLY. BRUNO IS WORKING WITH ACCESS ABILITIES TO CONDUCT ADDITIONAL TRAINING ON THE INSTALLATION, SERVICE, AND MAINTENANCE OF VERTICAL PLATFORM LIFT PRODUCTS. ADDITIONALLY, BRUNO WILL RE-TRAIN ACCESS ABILITIES ON THE EXPECTATIONS AND RESPONSIBILITIES REGARDING TIMELY COMMUNICATION WITH BRUNO. MORE DETAIL WILL BE PROVIDED AS PART OF THE 30 DAY FOLLOW UP OR AS IT IS ACQUIRED.

    Description of Event or Problem · 0

    ON FEBRUARY 27TH, 2023, BRUNO RECEIVED A LETTER DATED FEBRUARY 14TH, 2023, SENT VIA REGULAR MAIL FROM A (B)(6). THE SUBJECT OF WHICH WAS A 4TH HAND NOTIFICATION OF INJURIES SUFFERED BY AN ELDERLY WOMAN WITH MOBILITY ISSUES AND DEMENTIA IN (B)(6) CANADA WHEN USING AN UNGUARDED DOOR WHILE ELEVATOR WAS NOT ON THAT FLOOR. ACCORDING TO THE LETTER THE ELEVATOR HAD BEEN MOVED BY THE ELEVATOR COMPANY TECHNICIAN WHO WAS PRESENT WORKING ON THE UNIT. THE LETTER SAID SHE SUSTAINED INJURIES FROM THE FALL THAT OCCURRED ON EITHER (B)(6) 2021 WHILE USING THE WAUPACA ELEVATOR COMPANY UNIT INSTALLED IN A DAUGHTER'S HOME. THERE ARE CONFLICTING DATES LISTED ON THE SHORT LETTER AND WE WILL SHARE THE DATE WE BELIEVE ACCURATE IN THE MANUFACTURER'S NARRATIVE. THE LETTER STATED THE PATIENT PASSED AWAY ON (B)(6) 2021. WAUPACA ELEVATOR COMPANY WAS A WISCONSIN CORPORATION THAT WENT INTO RECEIVERSHIP IN MARCH OF 2022 AND THE ASSETS OF WHICH WERE PURCHASED BY FOX VALLEY ELEVATOR. WAUPACA ELEVATOR HAD A VERY WIDE BREADTH OF ELEVATOR MODELS INCLUDING IN-HOME RESIDENTIAL, COMMERCIAL, DUMBWAITERS AS WELL A FEW MOBILITY LIFT PRODUCTS THAT COMPETE WITH BRUNO MODELS AND ARE OFTEN SOLD TO THE SAME INDEPENDENT DEALER CHANNEL AS BRUNO. IT IS NOT UNCOMMON FOR BRUNO AS A WISCONSIN MANUFACTURER OF WHEELCHAIR ELEVATORS TO BE MISTAKEN FOR THE WAUPACA ELEVATOR/NOW FOX VALLEY ELEVATOR COMPANY. THERE WAS NO SERIAL NUMBER, MODEL NUMBER, BUILD DATE, CONFIGURATION OR ANY OF THE OTHER EASILY IDENTIFIABLE DATA PLATE INFORMATION OR OTHER DISTINGUISHING REFERENCE TO IDENTIFY THE UNIT. NOR WAS THERE A WARRANTY CARD REGISTERED IN ANY OF THE NAMES MENTIONED IN THE HOWIE, SACKS AND HENRY LETTER. A SEARCH OF ALL BRUNO COMPLAINT FILES FROM 6 MONTHS BEFORE THE LISTED ACCIDENT DATE TO THE LETTER RECEIPT DATE LISTED TURNED UP NO REPORTED INSTANCES WHERE A PERSON FELL DOWN A SHAFT WAY, NOR WERE ANY DEATHS REPORTED. ON MARCH 8TH, 2023, BRUNO WAS ABLE TO IDENTIFY THAT THE UNIT WAS A BRUNO VPL-3214B VERTICAL PLATFORM LIFT SN (B)(4). ON MARCH 20TH AFTER MANY ATTEMPTS, A DISCUSSION WITH THE INDEPENDENT CONTRACTOR (ACCESS ABILITIES) OCCURRED AND THIS INFORMATION IS SHARED IN DEVICE MANUFACTURER'S NARRATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250962 BRUNO VERTICAL PLATFORM LIFT PCE BRUNO INDEPENDENT LIVING AIDS, INC. VPL-3214B

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Hospitalization| D