BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XENEX XE

    MDR report key: 9191407 · Received October 15, 2019

    Report

    Report Number
    9191407
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    March 28, 2019
    Report Date
    March 28, 2019
    Manufacturer
    XENEX DISINFECTION SERVICES
    Product Code
    MKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A XENEX UV DISINFECTION SYSTEM WAS BROUGHT TO BIOMEDICAL ENGINEERING FOR REPAIR. THE TABLET THAT IS USED FOR THE DISPLAY AND CONTROLS WAS NOT WORKING AND WOULD NOT TURN ON. DURING THE REPAIR, IT WAS NOTED THAT THE RECHARGEABLE BATTERY IN THE ASUS TABLET HAD SWELLED, AND CAUSED THE TABLET'S CASE TO BULGE AND SPLIT OPEN. MANUFACTURER RESPONSE FOR TABLET, (BRAND NOT PROVIDED) (PER SITE REPORTER). XENEX IS SHIPPING A NEW TABLET TO US. WE WILL RETURN BROKEN TABLET TO XENEX. MANUFACTURER RESPONSE FOR UV LIGHT STERILIZER, XENEX XE (PER SITE REPORTER). XENEX IS SENDING A REPLACEMENT TABLET AND A SHIPPING LABEL TO RETURN THE BROKEN TABLET. WE WILL RETURN THE TABLET WITH SWOLLEN BATTERY TO XENEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983700 XENEX XE UV LIGHT STERILIZER MKB XENEX DISINFECTION SERVICES PXUV3D

    Patients

    Seq Age Sex Outcome Treatment
    1