BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVILBISS HEALTHCARE

    MDR report key: 13501150 · Received February 9, 2022

    Report

    Report Number
    2515872-2022-00004
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 3, 2022
    Report Date
    February 4, 2022
    Manufacturer
    DEVILBISS HEALTHCARE LLC
    Product Code
    JCX
    UDI-DI
    00885304000327
    PMA / PMN Number
    K982304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DEVILBISS HEALTHCARE WAS NOTIFIED ON (B)(6) 2022 OF A COMPLAINT INVOLVING A MODEL 7314P-D VACU-AID QSU PORTABLE SUCTION DEVICE. THE PATIENT'S MOTHER STATED SHE WAS USING UNIT TO SUCTION HER SON WHEN IT "STOPPED WORKING." SHE STATED THAT SHE "REMOVED THE HOSES" AND DETERMINED THE UNIT WAS NOT PRODUCING ANY SUCTION. THIS WAS NO REPORT OF ANY ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DEVILBISS HEALTHCARE IS CURRENTLY PERFORMING A PRODUCT EVALUATION AND WILL FILE UPDATE AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE. WE ARE FILING THIS COMPLAINT IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50236 DEVILBISS HEALTHCARE VACU-AID QSU JCX DEVILBISS HEALTHCARE LLC 7314P-D 00885304000327

    Patients

    Seq Age Sex Outcome Treatment
    1 Female