BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTAL PRO

    MDR report key: 621820 · Received July 8, 2005

    Report

    Report Number
    621820
    Event Type
    Malfunction
    Date Received
    July 8, 2005
    Date of Event
    July 5, 2005
    Report Date
    July 8, 2005
    Manufacturer
    OAKWORKS INC
    Product Code
    KMN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT CAME IN FOR INITIAL OUTPATIENT EVALUATION. PRIOR TO PLACING PATIENT IN THE MASSAGE CHAIR, THE LICENSED PHYSICAL THERAPIST SAT IN THE CHAIR TO CHECK IT OUT. THE PATIENT WAS ASSISTED INTO THE MASSAGE CHAIR. AS THE PATIENT SAT IN THE CHAIR THE SAFETY LATCH BROKE CAUSING THE CHAIR TO COLLAPSE. THE PATIENT WAS ASSISTED TO A STANDING POSITION AND ANOTHER MASSAGE CHAIR WAS BROUGHT INTO THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTAL PRO MASSAGE CHAIR KMN OAKWORKS INC PP27072-3126197 *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR