BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KION

    MDR report key: 5506981 · Received March 17, 2016

    Report

    Report Number
    8010042-2016-00147
    Event Type
    Malfunction
    Date Received
    March 17, 2016
    Report Date
    February 22, 2016
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K024213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2016 07:12 AM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): AFTER RECEIVING A CORRESPONDENCE FROM THE FDA REGARDING THE RECEIVED INITIAL E-MDR REPORT INDICATING THE E-MDR WAS 5 DAY AND A 30 DAY REPORT, A SUPPLEMENTAL REPORT WAS CREATED TO CORRECT THE INCORRECT SELECTION OF A 5-DAY REPORT INSTEAD OF THE INITIAL VALUE. THE INITIAL AND 30 DAY REPORT VALUES WERE MEANT TO BE SELECTED FOR THE RECEIVED INITIAL E-MDR REPORT.

    Additional Manufacturer Narrative · 1

    MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION SUCH AS THE SERVICE REPORT, PARTS REPLACED/EXCHANGED, OR THE DEVICE LOGS WERE ISSUED, BUT NOT PROVIDED. WITHOUT ADDITIONAL INFORMATION, WE ARE UNABLE TO CONFIRM OR DETERMINE THE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    (B)(6) 2016 07:09 AM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2016 06:49 AM (GMT-4:00) ADDED BY (B)(6) ((B)(4)): IT WAS REPORTED THAT A MEASURED VALUE DIFFERS FROM THE SET VALUE. IT IS NOT KNOWN IF THE ANESTHESIA WORKSTATION WAS USED ON A PATIENT AT THE TIME OF THE EVENT. NO INJURIES HAVE BEEN REPORTED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164284 KION GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1