BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPARK

    MDR report key: 2554387 · Received June 4, 2010

    Report

    Report Number
    3032367-2010-00002
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 4, 2010
    Report Date
    June 4, 2010
    Manufacturer
    SONOSITE, INC.
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE POWERPARK WAS EVALUATED IN ACCORDANCE WITH INFO FOR MFRS SEEKING MARKETING CLEARANCE OF DIAGNOSTIC ULTRASOUND SYS AND TRANSDUCERS, ISSUED (B)(4) 2008, "DECIDING IF SYS AND TRANSDUCER MODIFICATIONS REQUIRE ADD'L 510(K) PRE-MARKET NOTIFICATIONS OR ADD-TO-FILES" AND THE FDA "BLUE BOOK" MEMO, K97-1, DECIDING WHEN TO SUBMIT A 510(K) FOR A CHANGE TO EXISTING DEVICE. AS A RESULT OF THE EVAL, IT WAS DETERMINED THAT A NEW 510 (K) SPECIFIC TO THE RELEASE OF THE POWERPARK WAS NOT REQUIRED. THE POWERPARK IS AN ACCESSORY TO THE V UNIVERSAL AND H UNIVERSAL STAND, WHICH ARE ACCESSORIES TO THE MICROMAXX, MAXX SERIES (M-TURBO AND S-SERIES), AND NANOMAXX ULTRASOUND SYS. THE POWERPARK IS COMPRISED OF TWO PARTS: THE STAND MOUNTED ASSEMBLY WHICH IS MOUNTED TO THE V OR H UNIVERSAL STAND AND THE DOCKING ASSEMBLY WHICH IS PLUGGED INTO A WALL CIRCUIT. THE POWERPARK PROVIDES A DOCKING AND CHARGING STATION FOR THE V AND H UNIVERSAL STANDS TO ACCOMMODATE THE SONOSITE MICROMAXX, M-TURBO, S-SERIES AND NANOMAXX SYSTEMS, ALLOWING EITHER A POWERPACK BATTERY PACK OR SYS BATTERY TO BE CHARGED WHILE A STAND IS DOCKED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO CONNECT THEIR H-UNIVERSAL STAND TO THE POWERPARK, THE ALIGNMENT PINS ON THE STAND WERE NOT ALIGNED PROPERLY WITH THE FEMALE CONNECTOR ON THE POWER PARK, FORCING THE ALIGNMENT PIN TO RIDE HIGH, ABOVE THE INTENDED HOLE. WHEN THIS OCCURRED, THE PLASTIC COVER ON THE NEUTRAL PIN ON THE FEMALE CONNECTOR WAS DAMAGED, EXPOSING THE METAL PIN. THE METAL PIN ON THE FEMALE CONNECTOR MADE CONTACT WITH THE ALIGNMENT PIN ON THE STAND, CAUSING A SHORT BETWEEN THE NEUTRAL AND GROUND PINS WHICH INTERRUPTED THE GFCI AND RESULTED IN A LOT OF POWER AT THE ELECTRICAL OUTLET. NO OTHER HOSP EQUIPMENT WAS IMPACTED BY THE LOSS OF POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERPARK MEDICAL DIAGNOSTIC ULTRASOUND ACCESSORY IYO SONOSITE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other