BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER BATH

    MDR report key: 3420692 · Received September 23, 2013

    Report

    Report Number
    1419652-2013-00268
    Event Type
    Malfunction
    Date Received
    September 23, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    ILM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; "TEMPERATURE FLUCTUATING AND TOO HIGH, 50+ DEGREES C. SPOKE WITH HEAD MAINTENANCE, MAINTENANCE PERSONNEL DID NOT KNOW HOW TO TAKE OUT AND CLEAN THE CARTRIDGE. MAINTENANCE TURNING UP THE TEMPERATURE BECAUSE IT WAS TOO LOW, TEMPERATURE WAS TOO LOW BECAUSE THE CARTRIDGES WERE DIRTY. CLEAN FILL CARTRIDGE AND ADJUSTED THE FILL TEMPERATURE TO 42 DEGREES C. EXPLAINED TO HEAD MAINTENANCE TO EDUCATE MAINTENANCE STAFF NOT TO ADJUST THE TEMPERATURE WITHOUT CLEANING THE FILL CARTRIDGE." REFERENCE MFT REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480350 PARKER BATH ILM ARJO HOSPITAL EQUIPMENT AB AL14110-CA

    Patients

    Seq Age Sex Outcome Treatment
    1