BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 2871682 · Received December 11, 2012

    Report

    Report Number
    1525965-2012-00118
    Date Received
    December 11, 2012
    Report Date
    November 17, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT THAT THE CONSOLE UPS (UNINTERRUPTIBLE POWER SUPPLY) BATTERY WAS LEAKING ACID THAT RESULTED IN A BURNING SMELL. THE UPS BATTERY WAS CONTAINED IN THE BATTERY CABINET. THE FIELD SERVICE ENGINEER DETERMINED THERE WAS NO REPORT OR INDICATION OF SMOKE OR FIRE. THE CUSTOMER DID NOT CONTACT THE FIRE DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT AND NO ONE WAS INJURED. THERE IS POTENTIAL FOR CONTACT WITH BATTERY ACID OR ACID FUMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1