BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER BATH

    MDR report key: 2910215 · Received November 23, 2012

    Report

    Report Number
    9611530-2012-00203
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER ARJO (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER¿S INVESTIGATION.

    Description of Event or Problem · 1

    DOOR GAS STRUT PROBLEM INSPECTED UNIT FOUND THE DOOR STRUT BAD MAKING DOOR HEAVY TO LIFT AND NOT STAYING UP. REPLACED PARTS TESTED ON SERVICE. THIS EQUIPMENT WAS VOLUNTARILY TAGGED OUT FOR SERVICE BY THE CUSTOMER AND NOT USED WITH PATIENTS; IT IS UNLIKELY THERE WAS ANY POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARKER BATH BATH SYSTEMS ILJ ARJO HOSPITAL EQUIPMENT AB AL14111-US

    Patients

    Seq Age Sex Outcome Treatment
    1