BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMD III MODEL 9CSY0799-E

    MDR report key: 2477102 · Received March 1, 2012

    Report

    Report Number
    9616576-2012-00001
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 12, 2012
    Manufacturer
    DANISH DIAGNOSTIC DEVELOPMENT
    Product Code
    KPS
    PMA / PMN Number
    K011611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO ATTACHED INVESTIGATION SUMMARY, (B)(4), INVESTIGATION SUMMARY, LINEAR DETECTOR BEARING BREAKDOWN, CARDIOMD (B)(4). THIS WILL CLOSE THE HANDLING OF THIS INCIDENT. CONCLUSION: A RISK PRODUCT OF 10 WILL, ACCORDING TO DDD¿S RISK MGMT PROCEDURE, NOT CALL FOR ACTIONS FOR FURTHER MITIGATION TO REDUCE RISK. HOWEVER IT HAS BEEN DECIDED THAT DDD AND PHILIPS WILL INITIATE PREVENTIVE ACTIONS TO IMPROVE THE LUBRICATION INSTRUCTIONS FOR THE CARDIOMD. BASED ON THE SITE INSPECTIONS AND REPAIRS IT HAS BEEN CONFIRMED THAT THE CAUSE TO THE INCIDENT SYSTEM FAILURE WAS INSUFFICIENT LUBRICATION OF THE RAIL BLOCKS ON THE VERTICAL LINEAR BEARING FOR DETECTOR MOTION. DURING A COMPLETE RE-ASSEMBLING OF ALL RADIAL DETECTOR MOTION ALL PARTS WAS INSPECTION AND FOUND OKAY. THE FAILING LINEAR BEARINGS HAVE BEEN INSPECTED BY DDD. THE INSPECTION CONFIRMED THAT THE ROOT CAUSE TO THE INCIDENT WAS LACK OF LUBRICATION. IT WAS CONCLUDED THAT THE INCIDENT HAS BEEN CAUSED BY A HUMAN ERROR DURING SERVICE ROUTINES. THIS WILL CLOSE THE HANDLING OF THIS INCIDENT.

    Description of Event or Problem · 1

    THERE WAS A CARDIO MD BEARING BLOCK FAILURE (MALFUNCTION). WHEN THE CUSTOMER WENT TO MOVE HEADS UP SHE HEARD NOISE AND IMMEDIATELY STOPPED MOTION AND SHUT MACHINE DOWN. THE PHILIPS FIELD SAFETY ENGINEER (FSE) INSPECTED THE SYSTEM AND DETERMINED THAT THE BOTTOM OF BLOCK BROKE OFF AND BEARINGS FELL ONTO FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOMD III MODEL 9CSY0799-E NUCLEAR MEDICINE EQUIPMENT KPS DANISH DIAGNOSTIC DEVELOPMENT NA

    Patients

    Seq Age Sex Outcome Treatment
    1