BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 2508647 · Received March 21, 2012

    Report

    Report Number
    9611530-2012-00042
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 21, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE MFR ARJO (B)(4). IT WAS ALSO REPORTED THAT THE DEVICE WAS SOLD IN 2008 AND THERE ARE NO SERVICE RECORDS. IT WAS FOUND THAT THE MATTRESS WAS NOT GOOD AND THAT ONE OF THE SAFETY SIDE CATCHES COULD NOT BE SECURELY LOCKED. THE ON-SITE EVAL OF THE DEVICE HAS BEEN CARRIED OUT BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE FACILITY STATED THAT THE PT HAD FALLEN DURING SHOWERING PROCEDURES WHILE ON THE CONCERTO. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO SHOWER SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB BAB1000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other