BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET CONNECTING BRACKET

    MDR report key: 6975798 · Received October 25, 2017

    Report

    Report Number
    8010652-2017-00013
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    August 1, 2017
    Report Date
    October 4, 2018
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT IN QUESTION WAS INVESTIGATED BY THE QUALITY ASSURANCE DEPARTMENT FROM GETINGE, MAQUET GMBH. THE RETURNED PRODUCT WAS PRODUCED BEFORE 1996 AND HAS NO CE-LABEL. THE WELDED JOINT BETWEEN TWO COMPONENTS WAS FOUND TO BE BROKEN. AT THIS VERSION OF THE CONNECTING BRACKET THE TWO COMPONENTS WERE NOT YET COMPLETELY WELDED AROUND. FOR THE CURRENT VERSION OF THE CONNECTING BRACKET, THE WELDED JOINT WAS STRENGTHENED AND WELDED ALL AROUND. DUE TO THE RESULTS OF THE EXAMINATION OF THE DEFECTIVE CONNECTION ,WE ASSUME THAT THE WELD WAS DAMAGED / PRE-DAMAGED BY A LARGE FORCE (FOR EXAMPLE BY COLLISION WITH AN OBSTACLE). IT IS POSSIBLE THAT THE WELD SEAM WAS PRE-DAMAGED AND BROKE DURING FURTHER USE. 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 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).

    Additional Manufacturer Narrative · 0

    (B)(4) 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: (B)(4). CONTACT PERSON: (B)(4). IT WAS NOTED THAT DURING AN INTERNAL REVIEW, THE AWARE DATE ON THE DRAFT MEDWATCH FROM THE FACTORY WAS 09/26/2017; WHEREAS THE AWARE DATE NOTED ON THE MEDWATCH SUBMISSION WAS (B)(6) 2017. THIS WAS A TYPO ERROR ON BEHALF OF THE SSU. THIS SERVES TO CORRECT THE ERROR.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IN QUESTION WAS REQUESTED FOR INVESTIGATION. AT THE TIME OF THIS REPORT THE PRODUCT DID NOT ARRIVE AT (B)(4) - MAQUET (B)(4). AS SOON AS THE PRODUCT IS AVAILABLE AND THE INVESTIGATION WAS CONDUCTED A FOLLOW UP REPORT WILL BE SUBMITTED TO FDA. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT AFTER SURGERY WHEN THE PATIENT WAS TRANSFERRED FROM THE TABLE TOP TO THE PATIENT BED THE CONNECTING BRACKET OF A HEAD REST BROKE. NO INJURY HAS BEEN REPORTED TO (B)(4) - MAQUET (B)(4). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755090 MAQUET CONNECTING BRACKET ACCESSORIES, OPERATING-ROOM, TABLE (KIT) FWZ HOLGER ULLRICH 113054BO

    Patients

    Seq Age Sex Outcome Treatment
    1