BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 17139878 · Received June 15, 2023

    Report

    Report Number
    2438477-2023-00065
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Report Date
    June 15, 2023
    Manufacturer
    NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L
    Product Code
    OSI
    UDI-DI
    00822383212319
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BARIATRIC HOSPITAL BED BY AN END USER'S PARTNER, WHO REPORTED THAT THE FRAME WAS "BROKEN" AND THE END USER " FELL OFF THE BED AND HURT HER BACK AND BOTTOM." HE DID NOT SPECIFY ANY MEDICAL TREATMENT SHE RECEIVED. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778799 DRIVE BARIATRIC BED OSI NANTONG SHUNLONG PHYSICAL THERAPY EQUIPMENT CO., L 15300BV-PKG 00822383212319

    Patients

    Seq Age Sex Outcome Treatment
    1 Female