BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE VIDEO MONITOR, GVL-2000

    MDR report key: 3000140 · Received February 14, 2013

    Report

    Report Number
    9615393-2013-00063
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    VERATHON MEDICAL (CANADA) ULC.
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE RECEIVED THE DEVICE FOR FURTHER EVAL. SERVICE PLUGGED IN THE MONITOR AND THE CHARGE LED WAS BLINKING. THEN SERVICE OPENED THE UNIT AND SAW THAT THE WIRE FROM THE SWITCH TO THE POWER PCBA (POWER CIRCUIT BOARD ASSEMBLY) WAS DISCONNECTED. SERVICE RESOLDERED THE WIRE AND PUT THE UNIT BACK TOGETHER. SERVICE CONFIRMED THE REPORTED FAILURE WHICH WAS DUE TO A LOOSE WIRE FROM THE SWITCH TO THE POWER PCBA.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED VERATHON INC. REGARDING A PORTABLE VIDEO MONITOR, GVL-2000 THAT HAS A POWER MANAGEMENT ISSUE. THE PORTABLE VIDEO MONITOR, GVL-2000 WILL NOT HOLD CHARGE. THERE IS NO INJURY TO THE PT REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65386 PORTABLE VIDEO MONITOR, GVL-2000 NONE CCW VERATHON MEDICAL (CANADA) ULC. 0231-0003

    Patients

    Seq Age Sex Outcome Treatment
    1