BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESOPE RANGER MONITOR ASSEMBLY

    MDR report key: 2972140 · Received February 15, 2013

    Report

    Report Number
    9615393-2013-00072
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. THE SERVICE REP REPLACED A FAULTY BACK SHELL/INPUT CONNECTOR ASSEMBLY BECAUSE THE BATON WOULD NOT LOCK IN PLACE. ADDITIONALLY, THE DEVICE FAILED A LEAK TEST. THE SERVICE REP BUILT A NEW FRONT COVER ASSEMBLY AND GLUED IN A NEW WINDOW, A NEW ON OFF SWITCH, AND A NEW DC JACK ASSEMBLY. HE TRANSFERRED THE POWER PCBA AND LCD TO A NEW FRONT COVER ASSEMBLY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE CONNECTOR PORT ON THE MONITOR. THE GVL CABLES DID NOT STAY CONNECTED TO THE MONITOR. THE CUSTOMER TESTED MULTIPLE GVL BLADES TO CONFIRM THE ISSUE WAS WITH THE PORT ON THE MONITOR AND NOT THE CABLE CONNECTOR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69379 GLIDESOPE RANGER MONITOR ASSEMBLY NONE CCW VERATHON MEDICAL (CANADA) ULC. 0570-0186

    Patients

    Seq Age Sex Outcome Treatment
    1