BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARESCAPE V100 VITAL SIGNS MONITOR

    MDR report key: 2213988 · Received June 23, 2011

    Report

    Report Number
    3008729547-2011-00001
    Event Type
    Other
    Date Received
    June 23, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 23, 2011
    Manufacturer
    CRITIKON DE MEXICO S. DE R.L. DE C.V.
    Product Code
    MHX
    PMA / PMN Number
    K102426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS A DUPLICATE OF MFR REPORT # 9613557-2011-00013 WHICH WAS SUBMITTED ON (B)(4) 2011. THIS MFG SITE WAS RELOCATED IN (B)(4) 2011. THE NEW LOCATION AND ASSOCIATED REGISTRATION NUMBER IS 3008729547.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER SUPPLY ON THE DEVICE HAD SHORTED. THE USER PLUGGED THE UNIT INTO THE A/C WALL OUTLET, HEARD A LOUD POP AND SAW A SPARK. THE HOSPITAL STATED THAT THE REPORTED ISSUE WAS DUE TO USER ERROR AND NOT BECAUSE OF A PART FAILURE. THEY STATED THE USER HAD PLACED A PACK OF WET CLEANSING WIPES IN THE BASKET OF THE ROLLING STAND, AND THE LIQUID FROM THE WIPES SEEPED INTO THE POWER SUPPLY INPUT CONNECTOR, SO IT SHORTED OUT WHEN THE OPERATOR CONNECTED THE POWER CORD TO THE AC LINE. THERE WAS NO DAMAGE TO THE MONITOR AND NO USER OR PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESCAPE V100 VITAL SIGNS MONITOR PHYSIOLOGICAL PATIENT MONITOR MHX CRITIKON DE MEXICO S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1