BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER LIFT

    MDR report key: 18772939 · Received February 23, 2024

    Report

    Report Number
    3009402404-2024-00003
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 18, 2024
    Report Date
    February 23, 2024
    Manufacturer
    APEX HEALTHCARE MFG. INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT OR OTHER INFORMTION SUBMITTED BY JOERNS HEALTHCARE UNDER 21 CFR PART 803, AND AND RELEASE BY FDA OF THAT REPORT INFORMATION, DOES NOT REFLECT A CONCLUSION OR ADMISSION BY JOERNS HEALTHCARE , ITS EMPLOYEES, ITS CONTRACT SERVICE FIRMS, OR THEIR EMPLOYEES, FINISHED DEVICE SUPPLIERS, OR THEIR EMPLOYEES CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113820 HOYER LIFT PATIENT LIFT FSA APEX HEALTHCARE MFG. INC HOY-ADVANCE-E

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other