BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORIES - MEDICAL BEDS

    MDR report key: 3342569 · Received September 3, 2013

    Report

    Report Number
    3003984900-2013-00003
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Manufacturer
    HUNTLEIGH HEALTHCARE LTD.
    Product Code
    FNL
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETRACTOR HOUSING OF THE ADJUSTABLE STRAP AND HANDLE HAS BROKEN AS DETAILED IN NOTICE OF VOLUNTARY FIELD CORRECTION DATED 02/11/2011; CORRECTION NUMBER 1419652-2/11/11-001-C AND FDA RECALL #Z-1933-2011, THE ROIKO ADJUSTABLE STRAP AND HANDLE, TYPE TGN-R100GR, ARJOHUNTLEIGH PART NUMBERS CM-ACC09-I AND ENT-ACC01, PRODUCED BETWEEN 01/2007 AND 01/2009, RECALLED DUE TO PART OF THE HOUSING OF THE STRAP MECHANISM BUILT INTO THE HANDLE THAT MAY BREAK WHILE THE PT IS USING THE STRAP AND HANDLE; THE DATE CODE ON THE STRAP MECHANISM HOUSING FOR THIS COMPLAINT HAS BEEN CONFIRMED TO BE WITHIN THE SCOPE OF RECALL #Z-1933-2011, WHICH WAS OFFICIALLY COMPLETED AND REPORTED TO FDA AS SUCH ON 06/14/2011. IT WAS FOUND THE DEVICE WAS OUTSIDE OF SPECIFICATION WHEN THE PROBLEM WAS DETECTED, IT IS KNOWN IF THE DEVICE WAS IN USE AT THE TIME AS A RESULT LED TO ADVERSE EVENT. WHILST THIS CUSTOMER HAS REPORTED THE ISSUE TO US IT IS QUESTIONABLE WHETHER WE HAVE SUPPLIED THIS ACCESSORY TO THIS CUSTOMER OR WHETHER IT WAS SUPPLIED BY ANOTHER SUPPLIER. THIS BECAUSE THE CUSTOMER WAS NOT BEING SUPPLIED BY US DURING THE RECALL PERIODS OF 01/2007 AND 01/2009 BUT THE BROKEN ACCESSORY DOES FALL INTO THE RECALL CATEGORY. SO IN THE INTEREST OF COMPLETENESS OF TRANSPARENCY WE HAVE REPORTED THIS EVENT. WE SHALL RECOMMEND TO THE CUSTOMER TO REVIEW ANY ACCESSORIES AND TO REMOVE ANY THAT FALL INTO THE ROIKO TIME FRAME FROM USE. WE DO NOT PROPOSE ANY FURTHER ACTION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435529 ACCESSORIES - MEDICAL BEDS NONE FNL HUNTLEIGH HEALTHCARE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1