BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GETINGE 46-SERIES

    MDR report key: 3264606 · Received July 17, 2013

    Report

    Report Number
    9616031-2013-00002
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    August 14, 2010
    Report Date
    July 17, 2013
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO AN INCIDENT RESULTING IN MDR #9616031-2013-00001, A RETROSPECTIVE REVIEW OF SIMILAR COMPLAINTS IDENTIFIED THIS INCIDENT HAVING OCCURRED WITH NO MDR SUBMITTED. THE DEVICE INVESTIGATION CONCLUDED THAT THE HEATING ELEMENT WAS ACTIVATED WITHOUT WATER IN THE CHAMBER AND THAT THE OVERHEAT PROTECTION FAILED. A CORRECTION OF AFFECTED 46-4 WASHER-DISINFECTORS WAS INITIATED ON (B)(6) 2013 AND REPORT TO FDA IN PREPARATION. THE REPORT OF VOLUNTARY CORRECTION WILL BE SUBMITTED ON THE AGENCY BY OR PRIOR TO (B)(6) 2013.

    Description of Event or Problem · 1

    THE FIRE ALARMS WENT OFF AT 15:30 ON (B)(6) 2010. THE HOSPITAL USED THE WASHER LAST APPROX 21:00 (B)(6) 2010. NO OTHER DETAIL OF THE REPORT IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331942 GETINGE 46-SERIES WASHER DISINFECTOR MDZ GETINGE DISINFECTION AB 46-4

    Patients

    Seq Age Sex Outcome Treatment
    1