BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE

    MDR report key: 17260643 · Received July 5, 2023

    Report

    Report Number
    2438477-2023-00081
    Event Type
    Death
    Date Received
    July 5, 2023
    Report Date
    July 5, 2023
    Manufacturer
    NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BED BY A HOSPICE CENTER WHO STATED THAT "WHEN THE PATIENT WAS TRANSFERRED INTO THE BED, THE BED COMPLETELY COLLAPSED AND WAS IN FOUR PIECES AND THE PATIENT HAD TO BE LIFTED AND PLACED IN A WHEELCHAIR UNTIL A NEW BED WAS DELIVERED." THERE WAS NO INFORMATION PROVIDED REGARDING ANY SPECIFIC DEFECT IN THE UNIT, OR WHETHER THE ISSUE WAS RELATED TO THE ASSEMBLY OF THE BED. THE PATIENT REPORTEDLY DIED HOURS LATER, BUT THERE WAS NO INDICATION WHETHER THE DEATH WAS RELATED TO THE INCIDENT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO INSPECT THE UNIT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418000 DRIVE BED FNL NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L 15005LP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death