BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMEX

    MDR report key: 8279368 · Received January 25, 2019

    Report

    Report Number
    2428983-2019-00001
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    December 26, 2018
    Report Date
    January 25, 2019
    Manufacturer
    HOME MEDICAL PRODUCTS, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    LIFT WAS SHIPPED ON 01/10/2019 FROM THE CUSTOMER LOCATION TO APPLIED TECHNICAL SERVICES, INC. (ATS) FOR AN INDEPENDENT LABORATORY EVALUATION TO DETERMINE THE ROOT CAUSE OF FAILURE. A VERBAL PRELIMINARY OPINION FROM THE ENGINEERS FOLLOWING ATS INSPECTION WAS INCORRECT LIFT ASSEMBLY. ONCE A FINAL WRITTEN INVESTIGATION REPORT IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA, CUSTOMER AND MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT WHILE THE HOSPICE FACILITY WAS ATTEMPTING TO LIFT A PATIENT, THE TWO BOLTS HOLDING THE MAST OF THE LIFT INTO THE BASE BROKE. THE LIFT'S BOOM FELL HITTING THEIR PATIENT ON HIS HEAD. PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND SUFFERED FROM A CONTUSION. DIAGNOSIS AND FOLLOW-UP TREATMENT IS UNKNOWN. CUSTOMER STATED THEY HAVE NOT RECEIVED ANY FURTHER UPDATES RELATING TO THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69796 LUMEX PRO BATTERY POWERED FLOOR LIFT FSA HOME MEDICAL PRODUCTS, INC. LF500

    Patients

    Seq Age Sex Outcome Treatment
    1