BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIASPIRATOR

    MDR report key: 2728781 · Received September 4, 2012

    Report

    Report Number
    1931654-2010-00002
    Event Type
    Injury
    Date Received
    September 4, 2012
    Date of Event
    August 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    EVO MEDICAL SOLUTIONS
    Product Code
    BTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CERTIFIED LETTER WAS REC'D (B)(6) 2010, FROM A LAW FIRM WHO STATED: "BASED UPON OUR INVESTIGATION, WE BELIEVE THAT MEDICAL EQUIPMENT MANUFACTURED AND/OR SUPPLIED BY YOUR COMPANY CAUSED A FIRE TO OCCUR AT (ADDRESS WITHHELD), ON (B)(6) 2010, CAUSING THE DEATHS OF (NAME WITHHELD), (NAME WITHHELD), AND (NAME WITHHELD). (NAME WITHHELD) WAS SERIOUSLY INJURED AND HOSPITALIZED AS A RESULT OF THE FIRE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIASPIRATOR ASPIRATOR BTI EVO MEDICAL SOLUTIONS 601 CA3605006274

    Patients

    Seq Age Sex Outcome Treatment
    1 Death OTHER MEDICAL DEVICES WERE ALSO USED, CURRENTLY| PRODUCT NAMES ARE NOT KNOWN.