BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIV.A.C.¿ THERAPY SYSTEM

    MDR report key: 8921180 · Received August 22, 2019

    Report

    Report Number
    3009897021-2019-00163
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    July 23, 2019
    Report Date
    August 22, 2019
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION OBTAINED REGARDING THE DEVICE, KCI FOUND EVIDENCE THAT THE DEVICE HAD A COLLAPSED DOME. THERE IS NO INJURY ASSOCIATED WITH THIS EVENT. KCI IS REPORTING THIS EVENT FOUND DURING SERVICING OF THE UNIT AS A DEVICE MALFUNCTION THAT HAS THE POTENTIAL TO RESULT IN INJURY IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    ON (B)(6) 2019, KCI TECHNICAL SERVICES IDENTIFIED A COLLAPSED POWER BUTTON. ON (B)(6) 2019, KCI QUALITY ENGINEERING PERFORMED AN EVALUATION OF THE DEVICE. INSPECTION OF THE DEVICE FOUND THE POWER BUTTON WAS COLLAPSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717138 ACTIV.A.C.¿ THERAPY SYSTEM OMP OMP KINETIC CONCEPTS, INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1