BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO LOGIC

    MDR report key: 2508560 · Received March 23, 2012

    Report

    Report Number
    3005619970-2012-00002
    Event Type
    Injury
    Date Received
    March 23, 2012
    Date of Event
    February 24, 2012
    Report Date
    February 24, 2012
    Manufacturer
    GETINGE (SUZHOU) CO. LTD.
    Product Code
    JJJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED EXEMPTION (B)(4) BY ARJOHUNTLEIGH (REGISTRATION #1419652) ON BEHALF OF THE MANUFACTURER GETINGE (B)(4) (REGISTRATION #3005619970). MFR COMPLAINT #(B)(4). IT HAS BEEN REPORTED TO THE MANUFACTURER THAT AN INCIDENT HAS OCCURRED USING OUR: AUTO LOGIC (AL110) SYSTEM, COMPRISING OF AN ALTERNATING PRESSURE REDISTRIBUTION MATTRESS AND A PUMP. ON THE (B)(6), THE PATIENT WAS RECORDED AS HAVING A CATEGORY 3 PRESSURE ULCER (UNKNOWN AS TO THE LOCATION OF THE INJURY). IN ADDITION TO THE DETAILS RECORDED IN THIS REPORT, THE FOLLOWING WAS ALSO IDENTIFIED: DEVICE WAS EXAMINED AND THE GENERAL CONDITION WAS RECORDED AS "MATTRESS AND PUMP ARE IN GOOD CONDITION" WITH GOOD RESULTS OBSERVED FROM A FUNCTIONAL TEST. THERE WAS NO RECORDED ALTERATIONS TO THE SYSTEM PRIOR TO USE AND IT WAS NOT POSSIBLE TO RECREATE THE EVENT. TH ACTUAL DEVICE HAS NOT BEEN INVOLVED IN ANY SIMILAR INCIDENT IN THE LAST YEAR. THE IFU (USER MANUAL) WAS AVAILABLE TO THE USER, HOWEVER, THE PREVENTATIVE MAINTENANCE SCHEDULE FOR THIS DEVICE IS NOT AVAILABLE AT THIS MOMENT. THE DEVICE IS NOT UNDER ANY ARJOHUNTLEIGH SERVICE CONTRACT, BUT MAY BE UNDER A RENTAL AGREEMENT WITH OUR RENTAL DEPARTMENT. THE INFORMATION CONTAINED IN THIS INITIAL REPORT IS BASED UPON THE INFORMATION PROVIDED TO THE MANUFACTURER BY REPRESENTATIVES OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT ADMITTED SINCE (B)(6) 2011 ON SERVICE SP LOCO, HIGH PRESSURE ULCER RISK. STARTED WITH ALX IN RENTAL FLEET, AFTERWARDS REPLACED WITH AL110. REPLACED 1ST TIME WITH NEW PUMP DUE TO BOTTOMING OUT, SECOND TIME SAME PROBLEM. PATIENT ALREADY HAD PRESSURE ULCER WOUND, BUT HEALED AFTER WEEKEND AT HOME. ON (B)(6), NEW WOUND. MR. (B)(6) ALSO NOTICED THERE WAS A CRACK IN THE SEAT CUSHION IN THE WHEELCHAIR. THIS COULD HAVE CAUSED THE WOUND. PATIENT TREATED FOR WOUND CARE ACCORDING TO HOSPITAL PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO LOGIC PAC JJJ GETINGE (SUZHOU) CO. LTD. 630004BE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization