BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON RADIOLOGY

    MDR report key: 4134639 · Received September 25, 2014

    Report

    Report Number
    8022257-2014-00011
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Product Code
    LLZ
    PMA / PMN Number
    K043146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON IS ACTIVELY INVESTIGATING THE EVENT DISCOVERED AT THIS SITE TO DETERMINE THE ROOT CAUSE. ONCE THE INVESTIGATION IS COMPLETE, MCKESSON WILL SUBMIT A FOLLOW UP REPORT WITH THE EVALUATION SUMMARY.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT AN ARCHIVED PRIOR STUDY WAS UNAVAILABLE FOR A PATIENT DURING SURGERY. THE SITE ALLEGED THAT THE SURGERY WAS EXTENDED FOR APPROXIMATELY 45 MINUTES DUE TO THIS DELAY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599498 MCKESSON RADIOLOGY PICTURE ARCHIVING AND COMM. SYSTEM LLZ MCKESSON MEDICAL IMAGING COMPANY 12.0

    Patients

    Seq Age Sex Outcome Treatment
    1