BEUDAMED
    FDA Adverse Event Death Summary report: N

    VACUMAX

    MDR report key: 1676169 · Received May 4, 2010

    Report

    Report Number
    1931654-2010-00001
    Event Type
    Death
    Date Received
    May 4, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 29, 2010
    Manufacturer
    EVO MEDICAL SOLUTIONS
    Product Code
    BTA
    PMA / PMN Number
    K941961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). APRIL 2ND, 2010 - UNDER THE DIRECTION OF THE DME/HME THE 605 VACUMAX ASPIRATOR (B) (4) WAS CHECKED BY A FAMILY MEMBER (B) (6) 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. AS OF 04/29/2010, THE 605 DEVICE IS CURRENTLY NOT AVAILABLE TO THE MANUFACTURER FOR LAB TESTING TO CONFIRM ABOVE. THE DME/HME AND MANUFACTURER HAVE ASKED FOR ACCESS TO THE DEVICE, BUT HAVE BEEN DENIED. DEVICE (B) (4) WAS PART OF SHOP ORDER (B) (4) CONTAINING 100 DEVICES, OF THE 100 DEVICES NO DEVICES FAILED INSPECTION AND TESTING SPECIFICATIONS. A 605 WAS CHOSEN FOR LONG-TERM CYCLE BENCH TESTING STUDY. THE DEVICE WILL BE EVALUATED AND DATA GATHERED OVER A PERIOD OF MANY MONTHS OF CYCLING ON AND OFF PER 15 MINUTE CYCLES.

    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 VACUUMING 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 (B) (6) 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 MA BTA EVO MEDICAL SOLUTIONS 605 DA4709004862

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death THERAPY DATES| AUTHORITY FOR CONCOMITANT MEDICAL PRODUCTS AND| UNKNOWN - HOSPICE CARE WOULD BE THE MEDICAL