BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHYSIO COUCH

    MDR report key: 2223532 · Received July 21, 2011

    Report

    Report Number
    3003984900-2011-00023
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    FRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(6) BY (B)(6) ON BEHALF OF THE MFR ARJOHUNTLEIGH, A BRANCH OF (B)(4). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE HUNTLEIGH HEALTHCARE LTD (UNDER REGISTRATION #(B)(4)). AS OF 2011, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH, A BRANCH OF (B)(4) AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #(B)(4). THE FIXINGS HOLDING THE BACK REST IN PLACE ARE NOT THE ORIGINAL PARTS OF THE COUCH AND ARE NOT APPROVED AKRON PARTS. THE COUCH HAS BEEN MAINTAINED BY THIRD PARTY - WHO HAS NOT ADHERED TO AVAILABLE IFU AND USED INCORRECT PARTS. THE HEAD SECTION WAS BOLTED TO THE TOP FRAME BY THE CLIENT, INSTEAD OF USING THE CORRECT 10MM HINGE PINS, WHICH ARE READILY AVAILABLE. WHEN ARJOHUNTLEIGH SUPERVISOR ATTENDED THE SITE TO CARRY OUT THE INVESTIGATION, IT WAS FOUND THAT THE COUCH HAD BEEN REPAIRED AGAIN BY A THIRD PARTY, BUT NOT USING THE CORRECT AKRON PARTS; THE REPLACEMENT PARTS ARE NOT SUFFICIENT TO HOLD THE BACKREST. THE CORRECT PARTS HAVE NOW BEEN ORDERED BY ARJOHUNTLEIGH. THIRD PARTY COMPANIES SERVICE THE DEVICES, AND WHILE THE SERVICE MANUALS ARE READILY AVAILABLE, THE MFR HAS NO CONTROL OVER THE PARTS USED. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED WHERE THERE WERE UNAPPROVED COMPONENTS USED BY THIRD PARTY SERVICE COMPANIES LEADING TO THE REPORTED INCIDENT WITHIN THE PAST 15 MONTHS. DESPITE THIS, THE MFR WILL CONTINUE TO MONITOR FUTURE COMPLAINTS IN ORDER TO IDENTIFY ANY TRENDS.

    Description of Event or Problem · 1

    WHEN A LARGE PT SAT ON THE COUCH AND LEANED BACK ONTO THE BACK REST, BOTH BOLT FIXINGS ON THE BACK OF THE BACKREST SHEARED AND THE PT FELL BACKWARDS. THERE WERE NO INJURIES SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO COUCH CLINICAL COUCH FRK ARJOHUNTLEIGH 3222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other