BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHAMAX (460 MM LONGIT. SHIFT), EU

    MDR report key: 7944385 · Received October 8, 2018

    Report

    Report Number
    8010652-2018-00024
    Event Type
    Malfunction
    Date Received
    October 8, 2018
    Date of Event
    July 18, 2018
    Report Date
    October 8, 2018
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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). AFTER THE INCIDENT THE PATIENT COMPLAINED OF PAIN IN HER NECK. THE PATIENT'S NECK WAS EXAMINED BUT NO INJURY AS FOUND. THE PATIENT RECEIVED PHYSIOTHERAPY AFTERWARDS. IN THE MEAN TIME THE PATIENT REPORTED THAT SHE WAS NO LONGER IN PAIN. THE TABLE WAS EXAMINED BY THE CLINIC AFTER THE INCIDENT. NO DEFECT WAS DETECTED. A GETINGE-MAQUET SERVICE TECHNICIAN WAS ON SITE AND INVESTIGATED THE PRODUCT IN QUESTION. NO DEFECT WAS DETECTED. THEREFORE WE CONCLUDE THE HEAD PLATE WAS NOT CORRECTLY LOCKED AND CAME LOOSE DURING THE PROCEDURE . THE CLINIC RE-TRAINED THEIR STAFF IN THIS MATTER. GETINGE-MAQUET GMBH PROVIDES FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    DURING A PROCEDURE UNDER EPIDURAL ANESTHESIA, THE PATIENT WAS LIFTING HER HEAD FROM THE BED. THE HEAD SECTION OF THE BED UNEXPECTEDLY DETACHED FROM THE MAIN SECTION AND FELL TO THE FLOOR LEAVING THE PATIENT'S HEAD UNSUPPORTED. THE SECTION WAS REATTACHED AS QUICKLY AS POSSIBLE BUT THE PATIENT IS NOW COMPLAINING OF A SORE NECK. MFG REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782798 ALPHAMAX (460 MM LONGIT. SHIFT), EU TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 113322F5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other