BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SUPPLY/BATTERY CHARGER

    MDR report key: 1856570 · Received July 30, 2010

    Report

    Report Number
    3032367-2010-00005
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 29, 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 IS APPROVED 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 WHILE THE SYSTEM WAS CHARGING OVERNIGHT. 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 12/08

    Patients

    Seq Age Sex Outcome Treatment
    1 Other