BEUDAMED
    FDA Adverse Event Summary report: N

    CARDIOMD

    MDR report key: 4091947 · Received August 21, 2014

    Report

    Report Number
    1525965-2014-00149
    Date Received
    August 21, 2014
    Report Date
    July 23, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    KPS
    PMA / PMN Number
    K040616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IN THIS CASE, AN OPERATOR NOTICED AN ODOR COMING FROM THE CARDIOMD CAMERA. THE OPERATOR DESCRIBED THE ODOR WAS BURNT RUBBER BUT IT APPEARS THE SYSTEM IS RUNNING. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED AND FOUND THE BURNING SMELL WAS ORIGINATING FROM THE UNINTERRUPTIBLE POWER SUPPLY (UPS) ON THE CARDIOMD CAMERA. THE PHILIPS FIELD SERVICE ENGINEER (FSE) FOUND THAT THE BATTERIES IN THE UPS HAD FAILED ON THE SYSTEM. THE PHILIPS FSE STATED THAT BATTERIES WERE NOT SEALED AND THERE WAS BATTERY ACID LEAKAGE. THE PHILIPS FSE STATED THERE WAS NO REPORT OF SMOKE, FIRE, AND NO ALARMS WERE ACTIVATED AND THE FIRE DEPARTMENT WAS NOT CONTACTED. THE PHILIPS FSE TOOK THE SYSTEM OFF-LINE AND PLUGGED THE CARDIOMD DIRECTLY INTO THE WALL. THE CUSTOMER IS NOT UNDER CONTACT WITH PHILIPS HEALTHCARE AND CONTACTED THEIR BIO-MED DEPARTMENT ABOUT REPLACING THE UPS ON THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506546 CARDIOMD KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 882170

    Patients

    Seq Age Sex Outcome Treatment
    1