BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SUPPLY/BATTERY CHARGER

    MDR report key: 1856539 · Received June 25, 2010

    Report

    Report Number
    3032367-2010-00004
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Date of Event
    May 28, 2010
    Report Date
    June 25, 2010
    Manufacturer
    ELPAC
    Product Code
    ITX
    PMA / PMN Number
    K053069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)# - THE POWER SUPPLY ACCESSORY WAS CLEARED ON 11/16/2005 PER THE 510(K), K053069, SUBMITTED FOR THE MICROMAXX ULTRASOUND SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER SUPPLY ACCESSORY WHICH IS USED WITH THEIR MICROMAXX ULTRASOUND SYSTEM BURST OPEN. THIS EVENT OCCURRED DURING A PATIENT EXAM. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER SUPPLY/BATTERY CHARGER POWER SUPPLY ITX ELPAC 08/08

    Patients

    Seq Age Sex Outcome Treatment
    1 Other