BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 19341911 · Received May 16, 2024

    Report

    Report Number
    MW5155062
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Report Date
    May 14, 2024
    Manufacturer
    INOVO, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE INSTRUCTIONS ON THE DRIVE LIFT ARE VERY CONFUSING AND THIS POSES A SAFETY HAZARD. THEY APPEAR TO HAVE BEEN TRANSLATED FROM A FOREIGN LANGUAGE. THE PARTS ARE NOT CLEARLY LABELED IN A DIAGRAM. IT IS UNCLEAR HOW TO USE THE PRODUCT SAFELY. CLEARER INSTRUCTIONS WITH DIAGRAMS AND/OR A YOUTUBE VIDEO WOULD AID IN UNDERSTANDING SAFE USE. REFER TO ADD'L DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615044 DRIVE LIFT, PATIENT, NON-AC-POWERED FSA INOVO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male