BRUNO INDEPENDENT LIVING AIDS, INC.
Report
- Report Number
- 2131358-2024-00001
- Event Type
- Malfunction
- Date Received
- July 18, 2024
- Date of Event
- June 13, 2024
- Report Date
- July 16, 2024
- Manufacturer
- BRUNO INDEPENENT LIVING AIDS, INC.
- Product Code
- PCE
- UDI-DI
- 00642561000008
- PMA / PMN Number
- K061514
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 501
Narratives
THE BRUNO DEALER'S CREW OF INSTALLERS (INDEPENDENT CONTRACTOR TO BRUNO) WAS BEGINNING INSTALLATION OF SN (B)(6), A 4 FT VERTICAL PLATFORM LIFT ON THE JOB SITE BUT NOT AT THE FINAL LOCATION FOR THE UNIT. THE DESCRIPTION WAS PROVIDED BY THE PATIENT (INSTALLER#1) WHO WAS INJURED. THE INSTALLATION CREW IS EXPERIENCED AND HAS INSTALLED A VARIETY OF MANUFACTURER'S VPL UNITS SINCE 2012. HE ESTIMATED THAT THEY INSTALL APPROXIMATELY 10 TO 12 BRUNO VPL UNITS PER YEAR. THE 2-MAN CREW HAD REMOVED THE FRONT COVER TO EXPOSE THE UNIT WIRING AND CARRIAGE AS PART OF THE NORMAL INSTALLATION. THEY WERE IN THE PROCESS OF ATTACHING THE WHEELCHAIR PLATFORM TO THE CARRIAGE. WHILE THE PATIENT (INSTALLER #1) WAS KNEELING DOWN NEXT TO THE PLATFORM, THE OTHER INSTALLER STARTED SHAKING AND SHIMMING THE UNIT TO LINE UP THE PLATFORM (NOT THE TECHNIQUE SPECIFIED IN TRAINING) THE SPOT WELDS HOLDING THE CONTROL ENCLOSURE TO THE MOUNTING BRACKET BROKE FREE ALLOWING THE ENCLOSURE TO SWING DOWN AND GRAZE THE TOP OF THE PATIENT'S HEAD CAUSING AN APPROXIMATE 30MM LONG CUT TO THE SCALP IN THE HAIRLINE TO THE LEFT OF THE CROWN ON HIS HEAD. THE PATIENT (INSTALLER #1) TOLD BRUNO WHEN INTERVIEWED ON (B)(6) 2024 THAT HE FELT FINE, HE HAD RESUMED WORK WITHIN AN HOUR OF INCIDENT AND SYMPTOMS (LOW GRADE HEADACHE OR SORENESS IN SCALP) HAD GONE AWAY BY THE NEXT DAY. INSTALLERS ON THE SITE HAD ALREADY REATTACHED THE ELECTRICAL ENCLOSURE USING SHEET METAL SCREWS BEFORE CONTACTING BRUNO. THEY EXPLAINED THAT THEY CAREFULLY INSPECTED ALL OF THE CABLES AND ATTACHMENTS, FINDING NO DAMAGE AND MADE THE DECISION TO REATTACH WITH MECHANICAL FASTENERS AND COMPLETE THE INSPECTION. SO, THE UNIT IS NOT BEING RETURNED TO BRUNO FOR INSPECTION. UPON NOTIFICATION OF THE INCIDENT ALL BRUNO IN HOUSE STOCK WAS PUT ON HOLD, INSPECTED BY QUALITY TECHS AND FOUND TO BE CONFORMING AND RELEASED FROM QUALITY HOLD. THE NEXT 5 RECEIVED LOTS WILL GO THROUGH THE SAME INSPECTION PROCESS. ALL COMPLAINTS FOR THE LAST 6 MONTHS WERE REVIEWED TO SEE IF THERE WERE SIMILAR CASES. THREE OTHER CASES WITH CONTROLLER ENCLOSURE TO TOWER SEPARATION WERE THE RESULT OF SHIPPING DAMAGE. THIS VPL-3100 SERIES MODEL VPL-3153 HAS SUCCESSFULLY PASSED INDEPENDANT ISTA TRANSPORTATION TESTING FOR LTL TRANSIT THROUGH AN ACCREDITED LAB FACILITY. WITHIN THE LAST YEAR AND NO CHANGES HAVE BEEN MADE IN PACKAGING SINCE TESTING. A CAPA [(B)(4)] WAS OPENED UPON NOTIFICATION PER BRUNO PROCEDURE. THE SUBCONTRACTOR MAKING THE ENCLOSURE WELDMENT IS WORKING THROUGH A ROOT CAUSE ANALYSIS WITH BRUNO ENGINEERING AND QUALITY TEAM MEMBERS. A TRIP TO THE CONTRACTOR'S FACILITY WAS PERFORMED BY THE CHIEF ENGINEER FOR THE VPL LINE, THE VPL LINE SUSTAINING PROJECT ENGINEER, A QUALITY TECHNICIAN AND THE BUYER FOR THAT PRODUCT LINE. MET WITH THE SUB-CONTRACTOR'S QUALITY MANAGER AND WELD SUPERVISION PERSONNEL. RESULTS ARE EXPECTED BY THE END OF JULY WHEN THEY HAVE COMPLETED ANOTHER LOT THROUGH PRODUCTION.ADDITIONAL PHOTOGRAPHIC INFORMATION MAY BE AVAILABLE FROM THE INSTALLER TEAM, THEY ARE GOING TO CHECK THEIR INSTALLATION NOTES AND IF AVAILABLE, PROVIDE TO BRUNO BY JULY 19TH. BRUNO REALIZES THAT THIS REPORT IS BEING MADE A FEW DAYS LATER THAN THE 30 DAY INITIAL TIMELINE BUT DUE TO CONFLICTING INFORMATION ON THE INITAL REPORTS THE DECISION WAS MADE BY BRUNO TO DELAY SUBMISSION BY A FEW DAYS SO THAT THE DETAILS COULD BE CONFIRMED VIA AN INTERVIEW WITH THE PATIENT (INSTALLER #1). WE FELT THIS PROVIDES THE MOST ACCURATE INFORMATION OF THE INCIDENT. THE INTERVIEW WAS DELAYED DUE TO SEVERAL REASONS INCLUDING PATIENT (INSTALLER #1) TAKING EXTENDED TIME OFF AROUND THE 4TH OF JULY HOLIDAY.
THE BRUNO DEALER'S CREW OF INSTALLERS (INDEPENDENT CONTRACTOR TO BRUNO) WAS BEGINNING INSTALLATION OF SN (B)(6), A 4 FT VERTICAL PLATFORM LIFT ON THE JOB SITE BUT NOT AT THE FINAL LOCATION FOR THE UNIT. THE DESCRIPTION WAS PROVIDED BY THE PATIENT (INSTALLER#1) WHO WAS INJURED. THE 2-MAN CREW HAD REMOVED THE FRONT COVER TO EXPOSE THE UNIT WIRING AND CARRIAGE. THEY WERE IN THE PROCESS OF ATTACHING THE WHEELCHAIR PLATFORM TO THE CARRIAGE. WHILE THE PATIENT (INSTALLER #1) WAS KNEELING DOWN NEXT TO THE PLATFORM, THE OTHER INSTALLER (INSTALLER #2) STARTED SHAKING AND SHIMMING THE UNIT TO LINE UP THE PLATFORM (NOT THE TECHNIQUE SPECIFIED IN TRAINING) THE SPOT WELDS HOLDING THE CONTROL ENCLOSURE TO THE MOUNTING BRACKET BROKE FREE ALLOWING THE ENCLOSURE TO SWING DOWN AND GRAZE THE TOP OF THE PATIENT'S HEAD CAUSING AN APPROXIMATE 30MM LONG CUT TO THE SCALP IN THE HAIRLINE TO THE LEFT OF THE CROWN ON HIS HEAD. THE CUT STARTED TO BLEED, AND THE HOMEOWNER CALLED 911. THE EMT ARRIVED ON THE SCENE AND ASSISTED PUTTING PRESSURE ON THE CUT. THEY INSPECTED THE CUT AND DECIDED NO STITCHES OR BANDAGES WERE NECESSARY TO STOP THE BLEEDING. THE EMTS ASSISTED IN THE CLEANUP OF THE BLOOD AND MADE SURE THE PATIENT (INSTALLER #1) WAS FINE BEFORE LEAVING. THEY ADVISED HIM TO KEEP HYDRATED AND NOT DO STRENUOUS LABOR FOR THE REST OF THE DAY. THE PATIENT (INSTALLER #1) RESTED FOR A PERIOD OF ABOUT AN HOUR AND THEN CONTINUED TO ASSIST IN THE INSTALLATION. HAD A MILD HEADACHE AND SOME TENDERNESS IN THE HAIRLINE ADJACENT TO THE CUT. BOTH OF THESE SYMPTOMS HE SAID WERE GONE BY THE NEXT DAY. PATIENT (INSTALLER#1) IS ON BLOOD THINNERS AND SUSPECTS THAT IS WHAT CAUSED WHAT LOOKED LIKE A SIGNIFICANT AMOUNT OF BLOOD LOSS TO THE HOMEOWNER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1646159 | BRUNO INDEPENDENT LIVING AIDS, INC. | VERTICAL PLATFORM LIFT | PCE | BRUNO INDEPENENT LIVING AIDS, INC. | VPL-3153 | 00642561000008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male |