BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUATEC OCEAN

    MDR report key: 2659796 · Received July 3, 2012

    Report

    Report Number
    2659796
    Event Type
    Malfunction
    Date Received
    July 3, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 3, 2012
    Manufacturer
    AQUATEC OCEAN, DISTRIBUTED BY CLARKE HEALTH CARE PRODUCTS
    Product Code
    INB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PATIENT TOOK A SHOWER USING THE ROLLING COMMODE CHAIR. AFTER TAKING THE SHOWER THE NURSE ASSISTANT TURNED THE COMMODE AND A FRONT WHEEL SNAPPED OFF THE CHAIR. NO IMPEDIMENTS IN FLOOR DESIGN OR OTHER ENVIRONMENTAL ISSUES. THE CHAIR MATERIAL SHEARED AT CASTOR POSITION. PHOTOGRAPHS OF THE SHEARING ARE AVAILABLE.======================MANUFACTURER RESPONSE FOR SHOWER CHAIR/COMMODE, AQUATEC OCEAN (PER SITE REPORTER).======================DISTRIBUTOR IN CONTACT WITH MANUFACTURER TO DISCUSS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUATEC OCEAN SHOWER CHAIR/COMMODE INB AQUATEC OCEAN, DISTRIBUTED BY CLARKE HEALTH CARE PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR NO OTHER THERAPIES