BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET UNIVERSAL FRAME EU

    MDR report key: 7381329 · Received March 29, 2018

    Report

    Report Number
    8010652-2018-00007
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    March 6, 2018
    Report Date
    March 29, 2018
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THE PATIENT DEVELOPED PRESSURE ULCERS CAUSED DURING SURGERY WITH GETINGE-MAQUET PRODUCT. PRESSURE ULCERS CAN BE CAUSED DUE TO DIFFERENT INFLUENCES (PATIENT AGE, CONDITION OF SKIN, CONDITION OF PATIENT IN GENERAL, DURATION OF THE OPERATION, UNFAVORABLE POSITIONING OF THE PATIENT). NO PRODUCT FAILURE IS APPARENT WHICH CAUSED THE DESCRIBED INJURY. THEREFORE WE CONCLUDE IN THIS CASE THAT SEVERAL UNFAVORABLE FACTORS CAME TOGETHER AND THUS LED TO THE DESCRIBED INJURY. SINCE AN INJURY WAS REPORTED TO GETINGE-MAQUET WE ARE REPORTING THIS CASE TO THE AUTHORITIES. GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH, KEHLER STRASSE 31, RASTATT, GERMANY 76437. EXEMPTION # E2018004. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED PRESSURE ULCERS CAUSED DURING SURGERY WITH GETINGE-MAQUET PRODUCT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226409 MAQUET UNIVERSAL FRAME EU TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 100724A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other