BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIBU

    MDR report key: 2501448 · Received March 20, 2012

    Report

    Report Number
    9611530-2012-00039
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 20, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 MANUFACTURER ARJO (B)(4). THE ON-SITE EVAL OF THE DEVICE HAS BEEN CARRIED OUT BY A REP OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    ARJOHUNTLEIGH SERVICE ENGINEER ARRIVED AT THE FACILITY FOR A MALIBU BATH REPAIR; HE FOUND THAT THE BATH PANELS WERE NOT SECURED. UPON FURTHER INSPECTION, HE DISCOVERED THAT THE MIXER WAS SEVERELY DAMAGED AS 2 OF THE 4 MIXER PLATE SECURING BOLTS HAD SHEARED, RESULTING IN A GAP FORMING AT THE FRONT EDGE WHEN THE REAR BOLTS HAD BEEN TIGHTENED. THE INDIVIDUAL THAT HAD PREVIOUSLY PERFORMED SERVICE HAD THEN SEALED THIS GAP AND "GLUED" (SECURED) THE 2 BROKEN BOLTS WITH SILICON. NO INCIDENTS OR INJURIES TO PTS OR CAREGIVERS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALIBU BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB AJR1334-GB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other