BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASTVAC W/8 FOOT HOSE AND MOBILE STAND

    MDR report key: 3092181 · Received May 3, 2013

    Report

    Report Number
    0001811755-2013-01022
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    LGH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE. THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT OR USER INJURY AS A RESULT OF THIS EVENT AND REPORTED INFORMATION REGARDING THIS EVENT DOES NOT SUGGEST A RECURRENCE OF THIS EVENT WOULD RESULT IN A SERIOUS INJURY. CAST VAC DOES NOT COME IN DIRECT CONTACT WITH USER OR THE PATIENT. THERE WAS NO INDICATION OF SMOKE, FLAMES, OR SPARKS ASSOCIATED WITH THIS EVENT. IN THE PAST, THIS TYPE OF MALFUNCTION FOR THIS PRODUCT HAS NOT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THIS IS NOT A FILEABLE EVENT; THE REPORT WAS FILED IN ERROR.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION, SO THE REPORTED EVENT OF OVERHEATING COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASTVAC W/8 FOOT HOSE AND MOBILE STAND WAS ALLEGEDLY OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASTVAC W/8 FOOT HOSE AND MOBILE STAND WAS ALLEGEDLY OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASTVAC W/8 FOOT HOSE AND MOBILE STAND WAS OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194342 CASTVAC W/8 FOOT HOSE AND MOBILE STAND INSTRUMENT, CAST REMOVAL, AC-POWERED LGH STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1