BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLA 500/700

    MDR report key: 2130033 · Received May 4, 2011

    Report

    Report Number
    9611500-2011-00014
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    March 30, 2011
    Report Date
    May 4, 2011
    Manufacturer
    DRAGER MEDICAL GMBH
    Product Code
    FTD
    PMA / PMN Number
    K010724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. INVESTIGATION RESULTS WILL BE REPORTED IN A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CLEANING PROCEDURE, A SURGICAL LIGHT DETACHED FROM THE HOLDING ARM AND THAT THE USER ONLY JUST COULD HOLD THE LAMP. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLA 500/700 SURGICAL LIGHT FTD DRAGER MEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other