BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPACK

    MDR report key: 3379459 · Received September 3, 2013

    Report

    Report Number
    3032367-2013-00001
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    August 23, 2013
    Report Date
    August 23, 2013
    Manufacturer
    ICC-NEXERGY
    Product Code
    IYN
    PMA / PMN Number
    K130173
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWERPACK ACCESSORY IS APPROVED PER THE 510(K), K130173, SUBMITTED FOR THE M-TURBO ULTRASOUND SYSTEM. THERE ARE APPROX (B)(4) UNITS IN THE FIELD. INTERNAL TECHNICAL SUPPORT, EXTERNAL TECHNICAL SUPPORT, EXTERNAL DISTRIBUTORS AND THE POWERPACK MFR HAVE BEEN NOTIFIED OF THIS ISOLATED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWERPACK ACCESSORY CAUGHT FIRE AND STARTED TO SMOKE. THE CUSTOMER REPORTED THAT THERE WERE NO INJURIES TO THE USER OR PT. THE POWER PACK IS AN EXTERNAL BATTERY PACK EXTENDS THE SYSTEM BATTERY LIFE FOR PERFORMING MORE EXAMS ON A SINGLE CHARGE. THE SYSTEM WILL REMAIN OPERATIONAL VIA THE SYSTEM BATTERY AND EXTERNAL POWER SUPPLY W/O THE POWERPACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435729 POWERPACK MEDICAL DIAGNOSTIC ULTRASOUND ACCESSORY IYN ICC-NEXERGY P13559-01

    Patients

    Seq Age Sex Outcome Treatment
    1