AUTO LOGIC

Description of Event or Problem

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.

Additional Manufacturer Narrative

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.