BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO LOGIC

    MDR report key: 6112608 · Received November 18, 2016

    Report

    Report Number
    3007420694-2016-00236
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O. O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION #1419652). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJOHUNTLEIGH, A BRANCH OF ARJO LTD. MED AB (UNDER REGISTRATION #1000381138). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. CORRECTION: G4 - THE DATE OF A NEW INFORMATION WHICH ALLOWED TO ISSUE THE FOLLOW-UP REPORT WAS: 24-NOV-2016. THE FIRST FOLLOW-UP WAS SUBMITTED ON 16-DEC-2016. MANUFACTURER'S NARRATIVE: AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. BASED ON THE INFORMATION RECEIVED BY ARJOHUNTLEIGH AUTO LOGIC MATTRESS WAS SUSPECTED TO BE INVOLVED IN THE POTENTIALLY REPORTABLE EVENT DUE AN INITIAL ALLEGATION FROM SALES AND SERVICE UNIT REGARDING THE CPR MODULE WHICH WAS IMPOSSIBLE TO BE ACTIVATED. THE SYMPTOM WAS DISCOVERED IN THE SERVICE CENTER, HOWEVER, THE ORIGIN AND THE MOMENT OF PROBLEM OCCURRENCE WAS INITIALLY UNKNOWN. NO ADVERSE CONSEQUENCES OCCURRED, NO SERIOUS INJURY TO THE PATIENT OR USER HAS OCCURRED. ALONG WITH NEW INFORMATION RECEIVED, IT WAS POSSIBLE TO INDICATE THE REASON AND THE MOMENT OF CPR FAILURE - THE MODULE WAS ACCIDENTALLY DAMAGED IN THE SERVICE CENTER WHICH MITIGATES THE POTENTIAL FOR ANY RISK TO PATIENTS. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND NO OTHER RECORDS PRESENTING A SIMILAR SCENARIO TO THE ONE INVESTIGATED. ARJOHUNTLEIGH NO LONGER PERCEIVE THIS EVENT TO BE REPORTABLE. IT HAS BEEN ESTABLISHED THAT AUTO LOGIC MATTRESS (WHICH WAS MORE THAN 9 YEARS OLD) WAS RETURNED TO SERVICE CENTER AFTER THE RENTAL CONTRACT, WITH NO INDICATION FOR PARTICULAR COMPONENT'S FAILURE. AS A RESULT OF THE SERVICE PERFORMED ON THE MATTRESS THE CPR MODULE HAD TO BE REPLACED, WHICH WAS SUPPORTED BY THE COMMENT: "THE CPR DID NOT OPEN". IN THE COURSE OF INVESTIGATION IT WAS POSSIBLE TO CONFIRM THE SCENARIO AND CIRCUMSTANCES OF THE PROBLEM OCCURRENCE. THE CPR WAS DAMAGED IN THE SERVICE CENTER, DURING THE SERVICE. THE MODULE WAS PROBABLY HIT AGAINST THE TABLE WHILE BEING CLEANED WHICH RESULTED IN THE INTERNAL FAILURE AND IMPOSSIBILITY TO ACTIVATE THE MODULE. UNFORTUNATELY, THE PART WAS DISCARDED AND IT WAS NOT POSSIBLE TO CONDUCT THE EVALUATION AT THE MANUFACTURING SITE. IT IS WORTH TO MENTION THAT THE REVIEW OF SERVICE HISTORY REVEALED NO RECORDS OF PREVIOUS CPR MODULE REPLACEMENTS WHICH MAY SUGGEST THAT IT WAS THE ORIGINALLY FITTED MODULE WHICH FAILED. POSSIBLE SEQUENCE OF EVENTS PRESENTED ABOVE SEEMS TO BE THE MOST PROBABLE AND IN LINE WITH THE EVENT DESCRIPTION. BASING ON THE INFORMATION AVAILABLE, IT WAS FOUND THAT THE EVENT WAS MOST LIKELY CAUSED BY SALES REPRESENTATIVE ERROR - ACCIDENTAL MECHANICAL DAMAGE DURING THE SERVICE PROCEDURE. HOWEVER, THE DETERIORATION OF MATERIALS DURING THE YEARS OF USAGE MAY HAVE CONTRIBUTED TO THE OUTCOME OF CLAIMED FAILURE. ALTHOUGH NO SERIOUS INJURY TOOK PLACE, WE HAVE REPORTED THIS EVENT TO COMPETENT AUTHORITIES IN ABUNDANCE OF CAUTION, DUE TO THE LACK OF INFORMATION WHICH COULD HAVE EXCLUDED THE POTENTIAL FOR A HAZARDOUS SITUATION OCCURRENCE. HOWEVER, IN THE COURSE OF INVESTIGATION AND ALONG WITH NEW INFORMATION RECEIVED ARJOHUNTLEIGH NO LONGER FIND THIS EVENT TO COMPROMISE PATIENT'S OR USERS SAFETY. IT WAS POSSIBLE TO ESTABLISH THAT AUTO LOGIC SYSTEM WAS NOT IN USE FOR A PATIENT THERAPY AT THE TIME OF THE EVENT. HOWEVER, THE MATTRESS WAS FOUND TO HAVE MALFUNCTIONED (NOT PERFORMING UP TO THE SPECIFICATION) DUE TO MISUSE DURING SERVICE. ARJOHUNTLEIGH NO LONGER PERCEIVE THIS EVENT TO BE REPORTABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O. O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION #1419652). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJOHUNTLEIGH, A BRANCH OF ARJO LTD. MED AB (UNDER REGISTRATION #1000381138). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. ADDITIONAL INFORMATION WILL BE PROVIDED UPON THE INVESTIGATION CONCLUSION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O. O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION #1419652). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJOHUNTLEIGH, A BRANCH OF ARJO LTD. MED AB (UNDER REGISTRATION #1000381138). FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. IT HAS BEEN ESTABLISHED THAT AUTO LOGIC MATTRESS (WHICH WAS MORE THAN 9 YEARS OLD) WAS RETURNED TO SERVICE CENTER AFTER THE RENTAL CONTRACT, WITH NO INDICATION FOR PARTICULAR COMPONENT'S FAILURE. AS A RESULT OF THE SERVICE PERFORMED ON THE MATTRESS THE CPR MODULE HAD TO BE REPLACED, WHICH WAS SUPPORTED BY THE COMMENT: "THE CPR DID NOT OPEN". IN THE COURSE OF INVESTIGATION IT WAS POSSIBLE TO CONFIRM THE SCENARIO AND CIRCUMSTANCES OF THE PROBLEM OCCURRENCE. THE CPR WAS DAMAGED IN THE SERVICE CENTER, DURING THE SERVICE. THE MODULE WAS PROBABLY HIT AGAINST THE TABLE WHILE BEING CLEANED WHICH RESULTED IN THE INTERNAL FAILURE AND IMPOSSIBILITY TO ACTIVATE THE MODULE. UNFORTUNATELY, THE PART WAS DISCARDED AND IT WAS NOT POSSIBLE TO CONDUCT THE EVALUATION AT THE MANUFACTURING SITE. IT IS WORTH TO MENTION THAT THE REVIEW OF SERVICE HISTORY REVEALED NO RECORDS OF PREVIOUS CPR MODULE REPLACEMENTS WHICH MAY SUGGEST THAT IT WAS THE ORIGINALLY FITTED MODULE WHICH FAILED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2016, ARJOHUNTLEIGH EMPLOYEE WHO WAS PERFORMING SERVICE ON AUTO LOGIC MATTRESS HAS NOTICED THE MALFUNCTION OF THE CPR MODULE ON THE SERVICED MATTRESS - THE CPR COULD NOT HAVE BEEN OPENED WHEN TRYING TO RELEASE THE MECHANISM. THE TECHNICIAN HAS REPLACED THE CPR MODULE AND TESTED THE MATTRESS WITH A POSSITIVE RESULT. THIS REPAIR WAS PERFORMED ON A RENTAL MATTRESS - THE DEVICE WAS TESTED AFTER COMING BACK FROM THE RENTAL CONTRACT. THE MALFUNCTION WAS NOT REPORTED BY THE CUSTOMER - IT IS UNKNOWN WHETHER THE CPR MODULE WAS FULLY OPERATIVE UNTIL THE END OF THE CONTRACT OR THE MALFUNCTION OCCURRED DURING USE. NO INJURIES RESULTED FROM THE REPORTED MALFUNCTION. UNFORTUNATELLY THE PART WAS NOT KEPT FOR FURTHER EVALUATION. IT WAS NOT POSSIBLE TO DETERMINE ANY ADDITIONAL SYMPTOMS OF THE MALFUNCTION, NO CRACKS OR MATERIAL DAMAGES WERE INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763129 AUTO LOGIC MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB PXB001DAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other