BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE

    MDR report key: 15738334 · Received November 4, 2022

    Report

    Report Number
    2438477-2022-00103
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Report Date
    November 3, 2022
    Manufacturer
    HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD
    Product Code
    FNL
    UDI-DI
    00822383180328
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BED MOTOR AND HAND CONTROL BY AN END USER'S DAUGHTER, WHO STATED THAT "HER MOTHER WAS TRYING TO USE THE HAND CONTROL TO MOVE THE BED AND SPARKS STARTED COMING FROM THE MOTOR/WIRE THE HAND CONTROL CONNECTS TO." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THEY UNPLUGGED THE UNIT. NO ONE WAS HARMED AND THE FIRE WAS ONLY ON THE MOTOR/WIRES." THE PRODUCT WAS NEVER RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179260 DRIVE BED MOTOR FNL HANGZHOU DUNLI MEDICAL INSTRUMENTS CO.,LTD 15037MN 00822383180328

    Patients

    Seq Age Sex Outcome Treatment
    1 Female