BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYST 5VX

    MDR report key: 19918760 · Received August 6, 2024

    Report

    Report Number
    3005905321-2024-00007
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Manufacturer
    KI MOBILITY
    Product Code
    IOR
    UDI-DI
    00850013379033
    PMA / PMN Number
    K062660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION THAT HAS BEEN PROVIDED, IT APPEARS SOMEONE, OTHER THAN AN AUTHORIZED SUPPLIER (POSSIBLY END USER OR FAMILY), WORKED ON THE WHEELCHAIR BECAUSE IT IS MISSING A COMPONENT IN THE PHOTOGRAPHS. KI MOBILITY HAS MADE MULTIPLE ATTEMPTS TO GET MORE INFORMATION AND THE SUSPECT PARTS RETURNED SO WE CAN REVIEW AND DETERMINE WHAT MAY HAVE CAUSED THE STATED FALL. KI MOBILITY WILL UPDATE THIS REPORT WHEN THE PARTS ARE RETURNED OR MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FORK/STEM ASSEMBLY CAME OUT OF THE HOUSING WHILE THE END USER WAS IN THE CHAIR, CAUSING HIM TO FALL OUT. IT APPEARS THE CASTER HOUSING IS MISSING A COMPONENT PER THE PHOTO FURNISHED TO US. THAT COMPONENT WAS PRESENT AT TIME OF FINAL INSPECTION PRIOR TO SHIPPING. THIS APPEARS TO BE EVIDENCE OF IMPROPER SERVICING. THE HOUSING MAY HAVE ALLOWED THE FORK/STEM TO FALL OUT. THE CHAIR HAS NOT BEEN MADE AVAILABLE FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673788 CATALYST 5VX CATALYST IOR KI MOBILITY CATALYST 5VX 00850013379033

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other