BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALM

    MDR report key: 1413336 · Received June 25, 2009

    Report

    Report Number
    9710055-2009-00006
    Event Type
    Other
    Date Received
    June 25, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 1, 2009
    Manufacturer
    MAQUET S.A.
    Product Code
    FSS
    PMA / PMN Number
    K954169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE MAQUET REPRESENTATIVE VISITED THE HOSPITAL, AND DISCUSSED WITH THE STAFF. THEY REPORTED THAT ONE NURSE MOVED THE MOBILE UNIT BUT FORGOT TO UNPLUG THE DEVICE FIRST. THIS LIGHT HAS PASSED ALL SAFETY MECHANICAL AND ELECTRICAL TESTS ACCORDING TO IEC STANDARD. MOREOVER, THE USER MANUAL (REV 1C) PROVIDES INSTRUCTIONS TO "WIND THE POWER SUPPLY CABLE LOOSELY AROUND THE POWER SUPPLY HOUSING" THEN "RELEASE THE BRAKE" AND "MOVE THE LIGHT". THEREFORE, THE CAUSE OF THIS ISOLATED INCIDENT IS A FAILURE TO FOLLOW THE MANUFACTURER'S INSTRUCTIONS. MAQUET, INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A BLUE 30 MOBILE WAS DAMAGED DUE TO THE POWER CORD YANKING OUT OF THE POWER SUPPLY, LEAVING EXPOSED LIVE WIRES. THIS OCCURRED WHEN THE NURSE ROLLED THE LIGHT AWAY FROM THE WALL WITHOUT FIRST UNPLUGGING IT. THE CUSTOMER DID NOT REPORT ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALM FSS MAQUET S.A. BLUE 30 MOBILE

    Patients

    Seq Age Sex Outcome Treatment
    1