BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHAMAXX (460 MM LONGIT. SHIFT), EU

    MDR report key: 7272897 · Received February 15, 2018

    Report

    Report Number
    8010652-2018-00003
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 8, 2018
    Report Date
    May 24, 2018
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. (B)(4), CONTACT PERSON: (B)(6). THE TABLE WAS RETURNED TO RASTATT FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION THE ISSUE COULD BE REPRODUCED. THE INVESTIGATION REVEALED THAT A COMBINATION OF UNFAVORABLE CIRCUMSTANCES CAUSED THE DESCRIBED MALFUNCTION. THESE CIRCUMSTANCES WERE WORN OUT LOCKING BUFFERS CAUSING THE TABLE TO REST ON THE PLATES. THE PLATES HAVE A LOWER FRICTION COEFFICIENT THAN THE LOCKING BUFFERS. SWITCHES OUT OF ADJUSTMENT, IN A WAY THAT THE CASTORS STILL TOUCH THE FLOOR SLIGHTLY. SOFTWARE RELATED ISSUE. THE SOFTWARE FOR THE LOCKING FUNCTION MIGHT CAUSE THE CASTORS TO BE PRESSED TO THE FLOOR. THIS SCENARIO CAN OCCUR IF THE LOCKING KEY IS PRESSED FOR MORE THAN 2 SECONDS OR PRESSED , RELEASED AND PRESSED AGAIN. ALL THREE CIRCUMSTANCES HAVE TO COME TOGETHER TO CAUSE THE DESCRIBED ISSUE. THE WORN OUT LOCKING BUFFERS WERE REPLACED AND THE SWITCHES RE-ADJUSTED ACCORDING TO SPECIFICATION. SINCE THE LAUNCH OF THE 112222XX PRODUCT LINE IN 2008, MORE THAN (B)(4) PRODUCTS HAVE BEEN MANUFACTURED. THIS IS THE FIRST COMPLAINT IN WHICH THE DESCRIBED FAILURE HAS BEEN REPORTED TO US. GETINGE-MAQUET GNMH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    MFG REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    MAQUET SERVICE TECHNICIAN VISITED THE CLINIC AND INVESTIGATED THE PRODUCT IN QUESTION. THE DESCRIBED MALFUNCTION COULD NOT BE REPRODUCED. THE PRODUCT IN QUESTION WAS REQUESTED FOR INVESTIGATION. AT THE TIME OF THIS REPORT THE PRODUCT IS ON ITS WAY TO THE MANUFACTURER FOR INVESTIGATION. GETINGE - MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A SURGERY THE TABLE WENT FROM LOCK INTO UNLOCK WITHOUT ANYONE USING THE HAND CONTROL. IT WAS REPORTED THAT THIS WAS THE THIRD TIME THE TABLE DID THIS. NO INJURY HAS BEEN REPORTED TO GETINGE - MAQUET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117367 ALPHAMAXX (460 MM LONGIT. SHIFT), EU TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 113322B5

    Patients

    Seq Age Sex Outcome Treatment
    1