BEUDAMED
    FDA Adverse Event Summary report: N

    BRILLIANCE 64

    MDR report key: 3932083 · Received June 26, 2014

    Report

    Report Number
    1525965-2014-00125
    Date Received
    June 26, 2014
    Report Date
    June 4, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4). WE WILL FILE A FOLLOW-UP MDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT PR# (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SYSTEM CALIBRATION, AN UNINTERRUPTIBLE POWER SUPPLY (UPS) BATTERY ALARM WAS SOUNDING. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE BATTERY HAD LEAKED BATTERY ACID OUTSIDE THE UPS CABINET. THE FSE CONFIRMED THERE WAS NO HARM TO A PATIENT, OPERATOR, OR BYSTANDER DUE TO THIS ISSUE. THE FSE REPLACED THE FAILED UPS AND BATTERY TO RESOLVE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372986 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1