BEUDAMED
    FDA Adverse Event Summary report: N

    BB (BIGBORE) ONCOLOGY CT

    MDR report key: 2861772 · Received November 29, 2012

    Report

    Report Number
    1525965-2012-00110
    Date Received
    November 29, 2012
    Report Date
    November 1, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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) 2012.

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFORMATION WHERE THE CUSTOMER REPORTED AN UNUSUAL SMELL IN THE CT CONTROL ROOM. THE SYSTEM WAS NOT IN USE AT THIS TIME AND NO PATIENT WAS INVOLVED. PHILIPS SERVICE DETERMINED A FAILED UNINTERRUPTED POWER SUPPLY (UPS) BATTERY WAS THE SOURCE OF THE UNUSUAL SMELL AND THAT TWO CELLS OF THE FAILED BATTERY DID LEAK BATTERY ACID. THE LEAK OF THE BATTERY ACID WAS CONTAINED INSIDE THE BATTERY PACK AND THERE WAS NO LEAKAGE EXTERNALLY. THE OPERATOR OR PATIENT HAVE NO DIRECT EXPOSURE TO THE (B)(4) BATTERIES. ONLY TRAINED SERVICE PERSONNEL HAVE ACCESS TO THE BATTERIES WITH A POTENTIAL FOR CONTACT WITH BATTERY ACID OR ACID FUMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BB (BIGBORE) ONCOLOGY CT JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728243

    Patients

    Seq Age Sex Outcome Treatment
    1