BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAD REST WITH DOUBLE ARTICULATION

    MDR report key: 7719440 · Received July 25, 2018

    Report

    Report Number
    8010652-2018-00013
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    June 29, 2018
    Report Date
    January 3, 2019
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). GETINGE-MAQUET GMBH SERVICE TECHNICIAN VISITED THE CLINIC AND INVESTIGATED THE PRODUCT. DURING THE INVESTIGATION OF THE HEAD REST (113053BO) IT WAS FOUND THAT THE SWIVEL LOCKING MECHANISM FOR THE HEAD REST ATTACHMENT WAS NOT WORKING PROPERLY. THE LEVER FOR THE HEAD REST UP AND DOWN MOVEMENT WAS BENT AND ONE OF THE LOCKS FOR THE HEAD REST ATTACHMENT TO THE TABLE WAS DAMAGED. THE DEFECTIVE HEADREST WAS REQUESTED FOR FURTHER INVESTIGATION BUT AT THE TIME OF THIS REPORT THE REQUESTED PARTS HAD NOT BEEN RECEIVED. THE INVESTIGATION IS STILL ONGOING. GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH (B)(4). EXEMPTION # E2018004. (B)(4), CONTACT PERSON: (B)(6). THE AFFECTED PRODUCT WAS RETURNED TO RASTATT AND INVESTIGATED. A FUNCTIONAL CHECK WAS PERFORMED. EVEN THOUGH THE PRODUCT WAS IN POOR WORKING CONDITION, THE MALFUNCTION DESCRIBED BY THE CUSTOMER COULD NOT BE REPRODUCED. THERE FORE WE ASSUME USER ERROR TO BE THE MOST PROBABLE CAUSE FOR THE DESCRIBED MALFUNCTION. MOST LIKELY THE LOCKING MECHANISM WAS NOT LOCKED PROPERLY AND THIS LED TO THE DESCRIBED ISSUE. IN THE INSTRUCTIONS FOR USE (IFU) THE CUSTOMER IS ADVISED TO CHECK THE FIRM POSITION OF THE HEAD REST AFTER MOUNTING, INCLINING OR RAISING THE HEAD REST. QUOTES FROM THE IFU- "CHECK THE FIRM POSITION OF THE HEAD REST" AND WARNING! RISK OF INJURY! LOOSE OR LOOSENED SECURING ELEMENTS MAY CAUSE INJURIES. WHEN MOUNTING AND AFTER EVERY ADJUSTMENT, TIGHTEN AL THE LOCKING ELEMENTS (HANDLE SCREW, LOCKS, LEVERS, ETC) OF THE PRODUCT. CHECK THE FIRM SEATING OF THE LOCKING ELEMENTS." AS A RESULT OF THE INVESTIGATION, HINTS WERE FOUND INDICATING THIRD PART INTERVENTION. GREASE WAS FOUND ON A PART THAT SHOULD NOT BE LUBRICATED. PARTS SHOULD BE SECURED WITH GLUE WERE NOT SECURED WITH GLUE. IN THE IFU THE CUSTOMER IS WARNED NOT TO MODIFY THE PRODUCT. QUOTE IFU "DANGER! POTENTIALLY FATAL ! HAZARD CAUSED BY UNAUTHORIZED MODIFICATIONS. MODIFICATIONS OF THE PRODUCT ARE NOT PERMITTED." FURTHER THE INVESTIGATION REVEALED THAT MATERIAL OF A HARD PAPER PLATE WAS BROKEN OUT. ONE LEVER WAS BENT AND LOOSE. SUCH DAMAGE IS LIKELY DUE TO ROUGH HANDLING AND COLLISIONS. THE CUSTOMER IS WARNED IN THE IFU TO ONLY USE A PRODUCT THAT IS IN GOOD WORKING ORDER: "WARNING! HAZARD OF INJURY! ONLY OPERATE MAQUET PRODUCTS WHICH ARE IN FULLY FUNCTIONING CONDITION. BEFORE USE CHECK T SEE THE MAQUET PRODUCT IS FULLY FUNCTIONAL AND IN GOOD WORKING ORDER". GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT DURING A PROCEDURE THE HEAD ATTACHMENT COLLAPSED AND THE PATIENT SLID DOWN ON THE FLOOR. NO SERIOUS INJURY HAS BEN REPORTED TO GETINGE MAQUET GMBH. CT SCAN SHOWED NO INJURY, PATIENT SUBSEQUENTLY REPORTS MUSCULAR STRAIN AND DISCOMFORT. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563286 HEAD REST WITH DOUBLE ARTICULATION ACCESSORIES, OPERATING-ROOM, TABLE (KIT) FWZ HOLGER ULLRICH 113053BO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other