BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER SUPPLY / BATTERY CHARGER

    MDR report key: 2083075 · Received March 28, 2011

    Report

    Report Number
    3032367-2011-00001
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ELPAC
    Product Code
    IYN
    PMA / PMN Number
    K053069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NP
    Reporter Occupation
    PHYSICIAN

    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 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 IYN ELPAC 08/08

    Patients

    Seq Age Sex Outcome Treatment
    1 Other