BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL

    MDR report key: 8582297 · Received May 6, 2019

    Report

    Report Number
    8010652-2019-00015
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 6, 2019
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT A COMPARTMENT SYNDROME OCCURRED DURING SURGERY WITH A GETINGE-MAQUET PRODUCT. A GETINGE-MAQUET FIELD SERVICE ENGINGEER HAS VISITED THE CLINIC AND INVESTIGATED THE PRODUCTS IN QUESTION. HE CONFIRMED THAT NO DAMAGE OR MALFUNCTION COULD BE FOUND ON THE OR TABLE OR ATTACHED ACCESSORIES. FURHTER INFORMATION CONCERNING PATIENT DATA (AGE, WEIGHT, HEIGHT, PREEXISTING MEDICAL CONDITIONS), PERFORMED SURGERY AND PATIENT OUTCOME WAS REQUESTED FROM THE HOSPITAL. THE HOSPITAL REFUSED TO PROVIDE THIS INFORMATION DUE TO PROTECTION OF PERSONAL INFORMATION. A COMPARTMENT SYNDROME CAN BE CAUSED DUE TO DIFFERENT INFLUENCES ( PATIENT POSITION, OPERATING TIME, LITHOTOMY POSITION, ANKLE ABOVE HEART LEVEL, STRONG LOWER LEG AND / OR HIGH BMI, INTRAOPERATIVE COMPRESSION OF THE LARGE VESSELS, A HISTORY OF CARDIOVASCULAR ISSUES). SINCE NO PRODUCT MALFUNCTION WAS FOUND, WE ASSUME THAT IN THIS CASE SEVERAL UNFAVORABLE FACTORS CAME TOGETHER AND THUS LED TO THE DESCRIBED INJURY. GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    AT TIME OF THIS REPORT THE INVESTIGATION IS STILL ONGOING. WHEN THE INVESTIGATION IS COMPLETE THE REPORT WILL BE UPDATED AND A FOLLOW UP MEDWACHT WILL BE SUBMITTED. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF 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

    MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CASE OF COMPARTMENT SYNDROME OCCURRED. THE PATIENT WAS TREATED ON AN ALPHAMAXX TABLE. FURTHER INFORMATION CONCERNING PATIENT DATA, PERFORMED SURGERY, USED PRODUCT(S) AND MALFUNCTION WERE ASKED, BUT NOT YET PROVIDED WHEN THIS REPORT WAS CREATED. MANUFACTURER REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376929 ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 113302B3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other