BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNGO.PLAZA

    MDR report key: 8560710 · Received April 29, 2019

    Report

    Report Number
    3002808157-2018-11604
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    November 22, 2017
    Report Date
    December 22, 2017
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    LLZ
    PMA / PMN Number
    K132532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    RESUBMISSION OF INITIAL REPORT AS PER FDA ON 4/3/2019. ACTIVITIES ARE ONGOING TO EVALUATE THE EXACT AMOUNT OF AFFECTED DATA; HOWEVER, THE AFFECTED DATA IS CONSIDERED AS CLINICALLY RELEVANT. THE PRODUCT SYNGO.PLAZA DID NOT CONTRIBUTE TO THE DATA LOSS, AS THE ISSUE IS RELATED TO A HARDWARE FAILURE AND THE SYNGO.PLAZA IS A SOFTWARE SOLUTION ONLY (B)(6).

    Description of Event or Problem · 1

    PER THE POTENTIAL COMPLAINT REPORT, THERE WAS NO INJURY ASSOCIATED WITH THIS ISSUE. DUE TO AN IDENTIFIED HARDWARE FAILURE IN NETWORK ATTACHED STORAGE (NAS), THERE ARE MISSING FOLDERS CONTAINING PATIENT IMAGES IN THE CONFIGURED NAS (NAS1). A BACKUP NAS IS CONFIGURED, HOWEVER, IT IS MANAGED BY A 3RD PARTY APPLICATION AND NOT CONFIGURED IN THE SYNGO.PLAZA SYSTEM. CONTENTS OF NAS1 AND NAS2 ARE IDENTICAL. BOTH NAS SYSTEMS HAVE A LARGE AMOUNT OF EMPTY FOLDERS FOR DATES RANGING BETWEEN JANUARY 6, 2017 AND APRIL 19, 2017. THE REPORTED ISSUE OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353356 SYNGO.PLAZA PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM LLZ SIEMENS HEALTHCARE GMBH 10863171

    Patients

    Seq Age Sex Outcome Treatment
    1 Other