BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 17263731 · Received July 5, 2023

    Report

    Report Number
    2438477-2023-00090
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Report Date
    July 5, 2023
    Manufacturer
    NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, 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 THE END USER "FELL DUE TO A BED MALFUNCTION." THERE WAS NO INFORMATION PROVIDED REGARDING ANY SPECIFIC DEFECT IN THE UNIT, OR WHETHER THE ISSUE WAS RELATED TO THE ASSEMBLY OF THE BED. 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
    1788267 DRIVE BED FNL NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L 15216P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown