BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC CONSOLE FOR THE PAL SYSTEM

    MDR report key: 5053321 · Received September 3, 2015

    Report

    Report Number
    2020601-2015-00073
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    January 29, 2015
    Report Date
    September 3, 2015
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS
    Product Code
    MUU
    PMA / PMN Number
    D011615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO A DELAY IN SURGERY, IT WAS DETERMINED THE INCIDENT IS REPORTABLE. DURING A FILE REVIEW, IT WAS FOUND THAT THIS INCIDENT HAD NOT BEEN REPORTED TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE DEVICE STOPPED WORKING DURING SURGERY. THERE WAS A DELAY IN SURGERY; HOWEVER, THERE WERE NO INJURIES IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585415 ELECTRIC CONSOLE FOR THE PAL SYSTEM CONSOLE MUU MICROAIRE SURGICAL INSTRUMENTS 5020

    Patients

    Seq Age Sex Outcome Treatment
    1