BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J7P GJ MEDICAL CHAIR

    MDR report key: 390880 · Received April 24, 2002

    Report

    Report Number
    390880
    Event Type
    Malfunction
    Date Received
    April 24, 2002
    Date of Event
    April 1, 2002
    Report Date
    April 24, 2002
    Manufacturer
    KAG INDUSTRIES
    Product Code
    KMN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER PURCHASED 12 CHAIRS FROM KAG IND FOR DIALYSIS UNIT. SHORTLY AFTER RECEIVING THEM REPORTER RECEIVED A COMPLAINT THAT THE TACKS HOLDING THE VINYL FABRIC ON THE CHAIRS WAS EITHER STICKING OUT, OR FALLING OUT. THE CHAIRS WILL NOT RECLINE IN TRENDELENBERG POSITION AS PROMISED. BOTH PROBLEMS ARE JEOPORDIZING THE DIALYSIS PT'S SAFETY. THE CO ISN'T OFFERING A SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J7P GJ MEDICAL CHAIR DIALYSIS CHAIR RECLINER KMN KAG INDUSTRIES J7P-CR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other ONGOING AS PER DIALYSIS TREATMENTS