BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 1842728 · Received August 31, 2010

    Report

    Report Number
    9611530-2010-00058
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER ON THE 2010 (B)(6): PER THE AHUS SERVICE TECH - "THE CAREGIVER WAS BATHING THE RESIDENT AND HAD HIM TURNED TO HIS SIDE WHEN HE HEARD A CLICK AND THE RESIDENT HIT THE FLOOR." FURTHER FINDINGS FROM THE TECH ARE THAT THE SHOWER TROLLEY IS IN GOOD CONDITION EXCEPT THAT THE HEAD END OF THE LEFT SIDE HANDRAIL DOESN'T CLIP IN." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO BED, HYDRAULIC, ADJUSTABLE HOSPITAL FSA ARJO HOSPITAL EQUIPMENT AB BAB1000-01

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR