BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROADRUNNER

    MDR report key: 16532 · Received September 30, 1994

    Report

    Report Number
    MW1003557
    Event Type
    Malfunction
    Date Received
    September 30, 1994
    Date of Event
    June 1, 1994
    Report Date
    September 23, 1994
    Manufacturer
    AIR-SHIELDS VICKERS, INC.
    Product Code
    FPL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING TRANSPORT, DC POWER WAS LOST. OF THE FOUR CLIPS ON THE TWO BATTERIES, THREE CLIPS WRE FOUND TO BE DISCONNECTED. RPTR FOUND THAT THE CLIPS' OPENING HAD WIDENED AND LOOSENED. RPTR CHECKED TWO OTHER INCUBATORS AND FOUND THAT ALL THE CLIPS ON ONE WERE VERY LOOSE AND OFFERED NO RESISTANCE TO REMOVAL. RPTR BELIEVES THAT THE CLIPS USED MAY BE INADEQUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROADRUNNER TRANSPORT INCUBATOR FPL AIR-SHIELDS VICKERS, INC. TI 100

    Patients

    Seq Age Sex Outcome Treatment
    1 *