BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCUMAX QC COMPLETE

    MDR report key: 3912343 · Received June 26, 2014

    Report

    Report Number
    1824206-2014-01849
    Event Type
    Other
    Date Received
    June 26, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    IOQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE SACRUM AREA OF THE MATTRESS WAS NOT AS FIRM AS THE REST OF THE MATTRESS AND THE FOAM HAS LOST ITS RESILIENCY. THE PATIENT HAS DEVELOPED AN UNSTAGEABLE DEEP TISSUE INJURY. THE TECHNICIAN REPLACED THE MATTRESS TO RESOLVE THE ISSUE. THE PATIENT WAS TREATED WITH OINTMENTS AND DRESSINGS BUT NO SURGERY WAS REQUIRED. HE WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2014. AN ENGINEERING INVESTIGATION WILL BE PERFORMED. THE INVESTIGATION IS ONGOING, HOWEVER, IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE MATTRESS IS NOT INFLATING AND THE PATIENT HAS DEVELOPED OPEN WOUNDS. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373030 ACCUMAX QC COMPLETE BED FLOTATION THERAPY POWERED IOQ HILL-ROM, INC. PAISF9310384

    Patients

    Seq Age Sex Outcome Treatment
    1 Other