BRUNO INDEPENDENT LIVING AIDS, INC.
Report
- Report Number
- 2131358-2022-00001
- Event Type
- Injury
- Date Received
- January 13, 2022
- Date of Event
- December 14, 2021
- Report Date
- January 13, 2022
- Manufacturer
- BRUNO INDEPENDENT LIVING AIDS, INC.
- Product Code
- PCE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 501
Narratives
CURRENT DEALER INFORMED BRUNO ON 12-15-2021. DEALER REPORTED THAT THEY HAD BEEN ON SITE ON 12-01-2021, TO REPLACE DRIVE COMPONENTS OF THE UNIT AND PERFORM MAINTENANCE. THEIR RECORDS INDICATED THERE WAS A SERVICE CALL 10/11/21 TO LOOK AT DRIVE TRAIN. THE CURRENT DEALER INFORMED US THAT END USER HAD A DIFFERENT DEALER ON SITE IN MARCH OR APRIL OF 2021. THE ORIGINAL DEALER THAT INSTALLED THE UNIT IS DIFFERENT FROM EITHER OF THE TWO ABOVE DEALERS. BRUNO CONTACTED THE DEALER ON 12-15-2021 AND SENT CHIEF ENGINEER FOR THE PRODUCT LINE TO CONDUCT ON-SITE FOR INSPECTION. THIS INSPECTION WAS DELAYED AT END USER'S REQUEST TO JANUARY. THE INITIAL ANALYSIS INDICATES THAT THE MAIN DRIVE NUT WORE TO FAILURE CAUSING THE PLATFORM TO FALL ON THE SAFETY NUT, AS INTENDED. THE SAFETY SWITCH HOWEVER DID NOT ENGAGE AND THUS ALLOWED THE UNIT TO RIDE ON SAFETY NUT. THE SAFETY NUT THEN FAILED CAUSING THE UNIT TO FAIL. ADDITIONAL INVESTIGATION IS BEING CONDUCTED TO DETERMINE WHAT MAY HAVE PREVENTED THE SAFETY SWITCH FROM BEING ACTIVATED.
CURRENT DEALER INFORMED BRUNO ON 12-15-2021. DEALER REPORTED THAT THEY HAD BEEN ON SITE ON 12-01-2021, TO REPLACE DRIVE COMPONENTS OF THE UNIT AND PERFORM MAINTENANCE. THEIR RECORDS INDICATED THERE WAS A SERVICE CALL 10/11/2021 TO LOOK AT DRIVE TRAIN. THE CURRENT DEALER INFORMED US THAT END USER HAD A DIFFERENT DEALER ON SITE IN MARCH OR APRIL OF 2021. THE ORIGINAL DEALER THAT INSTALLED THE UNIT IS DIFFERENT FROM EITHER OF THE TWO ABOVE DEALERS. BRUNO CONTACTED THE DEALER ON 12-15-2021 AND SENT CHIEF ENGINEER FOR THE PRODUCT LINE TO CONDUCT ON-SITE FOR INSPECTION. THIS INSPECTION WAS DELAYED AT END USER'S REQUEST TO JANUARY. THE INITIAL ANALYSIS INDICATES THAT THE MAIN DRIVE NUT WORE TO FAILURE CAUSING THE PLATFORM TO FALL ON THE SAFETY NUT, AS INTENDED. THE SAFETY SWITCH HOWEVER DID NOT ENGAGE AND THUS ALLOWED THE UNIT TO RIDE ON SAFETY NUT. THE SAFETY NUT THEN FAILED CAUSING THE UNIT TO FAIL. ADDITIONAL INVESTIGATION IS BEING CONDUCTED TO DETERMINE WHAT MAY HAVE PREVENTED THE SAFETY SWITCH FROM BEING ACTIVATED.
THE EVENT WAS DESCRIBED TO THE MANUFACTURER THIRD HAND. END USER HAS A VPL-3214B UNIT INSTALLED WITH AN UNENCLOSED EXTERIOR APPLICATION IN A COASTAL REGION SETTING. ON (B)(6)2021, THE HUSBAND WAS OPERATING THE UNIT, STANDING ON THE PLATFORM, WHILE IT DESCENDED. IT WAS REPORTED THAT THE UNIT DROPPED WITHOUT NOTICE, INJURING HIS ANKLE. WIFE DROVE HIM TO THE HOSPITAL.
THE EVENT WAS DESCRIBED TO THE MANUFACTURER THIRD HAND. END USER HAS A VPL-3214B UNIT INSTALLED WITH AN UNENCLOSED EXTERIOR APPLICATION IN A COASTAL REGION SETTING. ON (B)(6)2021, THE HUSBAND WAS OPERATING THE UNIT, STANDING ON THE PLATFORM, WHILE IT DESCENDED. IT WAS REPORTED THAT THE UNIT DROPPED WITHOUT NOTICE, INJURING HIS ANKLE. WIFE DROVE HIM TO THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 807147 | BRUNO INDEPENDENT LIVING AIDS, INC. | VERTICAL PLATFORM LIFT | PCE | BRUNO INDEPENDENT LIVING AIDS, INC. | VPL-3214B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Hospitalization |