BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASTVAC W/8 FOOT HOSE AND MOBILE STAND

    MDR report key: 3192164 · Received June 27, 2013

    Report

    Report Number
    0009616696-2013-00004
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 5, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LGH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, USED FOR WATER AND SPARKS CAME OUT, WAS CONFIRMED. DURING TESTING THE SERVICE TECH OBSERVED THAT THE DEVICE WAS USED FOR WATER, AS VISUAL INSPECTION FOUND THE PC BOARD, MOTOR, ROCKER SWITCH, MID AND BOTTOM CANISTERS, AND RECEPTACLE WERE ALL DAMAGED DUE TO WATER. THE DEVICE IS DESIGNED TO VACUUM DRY MATERIAL ONLY. THE IFU CLEARLY STATES TO NOT USE THE CASTVAC TO VACUUM WET MATERIAL, AND IF USED AS A WET VACUUM THE CASTVAC COULD PRESENT AN ELECTRICAL SHOCK HAZARD. BASED ON THE RISK ASSESSMENT, IFU, AND CASES WITH SIMILAR REPORTED EVENTS THIS FAILURE CAN CAUSE SPARKING AND A POSSIBLE SHOCK TO A USER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT THE EVALUATION HAS NOT YET BEGUN. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SPARKS CAME OUT OF THE CASTVAC W/8 FOOT HOSE AND MOBILE STAND WHEN IT WAS USED TO SUCTION WATER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SPARKS CAME OUT OF THE CASTVAC W/8 FOOT HOSE AND MOBILE STAND WHEN IT WAS USED TO SUCTION WATER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291909 CASTVAC W/8 FOOT HOSE AND MOBILE STAND INSTRUMENT, CAST REMOVAL, AC-POWERED LGH STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1