BEUDAMED
    FDA Adverse Event Death Summary report: N

    VACUMAX

    MDR report key: 1673449 · Received April 29, 2010

    Report

    Report Number
    MW5015785
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 29, 2010
    Manufacturer
    MEDICAL INDUSTRIES AMERICA DBA EVO MEDICAL SOLUTIONS
    Product Code
    BTA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FAMILY OF A (B) (6) MALE - (B) (6). - IN HOSPICE CARE FOR AMYOTROPHIC SCLEROSIS, COMPLAINED THAT THE PORTABLE ASPIRATOR WAS NOT AS STRONG AS A PREVIOUS SUCTION MACHINE MADE BY A DIFFERENT MANUFACTURER. THE PATIENT SAID THE ASPIRATOR DID EXTRACT SECRETIONS, BUT IT TOOK LONGER THAN THE PREVIOUS SUCTION MACHINE. PER THE INSTRUCTION OF A DME/HME, THE ASPIRATOR WAS CHECKED BY A FAMILY MEMBER FOR LEAKS BY VACUUMING WATER, NO LEAKS WERE REPORTED, THE VACUUM PRESSURE WAS ALSO CHECKED BY A FAMILY MEMBER AND FOUND TO BE TO 20PSI, NORMAL MAXIMUM VACUUM. A FEW DAYS LATER THE PATIENT PASSED AWAY; THE FAMILY IS ASSOCIATING HIS PASSING WITH THE ASPIRATOR. AS OF 4-29-2010, THE ASPIRATOR IS CURRENTLY NOT AVAILABLE FOR LAB TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACUMAX PORTABLE ASPIRATOR, PORTABLE SUCTION DEVICE BTA MEDICAL INDUSTRIES AMERICA DBA EVO MEDICAL SOLUTIONS 605 DA4709004862

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death REGULATOR - MODEL & MFG UNK| PORTABLE O2 SYSTEM - MODEL & MFG UNK| BIBAP WITH HUMIDFIER - MODEL & MFG UNK| CONCENTRATOR - MODEL & MFG UNK| TUBING| O2 CYLINDERS