BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLES TOGO

    MDR report key: 2732746 · Received September 6, 2012

    Report

    Report Number
    MW5026808
    Event Type
    Malfunction
    Date Received
    September 6, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    CABLES TOGO
    Product Code
    LDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT PURCHASED THROUGH GSA (CABLES TOGO). WITH NO UL APPROVAL ON HOSPITAL GRADE POWER CORDS. POWER CORDS WERE LISTED AS MADE IN THE USA. THE POWER CORDS WERE SOLD AND RESOLD (B)(4), BEFORE RECEIVING THEM FROM (B)(4). I HAVE ALSO FOUND MANY OEM REPLACEMENT POWER CORDS DO NOT MEET THE STANDARD. BOTTOM LINE WHEN EQUIPMENT, IS REMANUFACTURED OVERSEAS, THE SAME SAFETY REQUIREMENTS ARE NOT FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CABLES TOGO 16 AWG HOSPITAL GRADE POWER CORDS LDQ CABLES TOGO 48000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other