BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAY CARE SUPPORTIVE BACKREST

    MDR report key: 159191 · Received March 26, 1998

    Report

    Report Number
    MW4002174
    Event Type
    Malfunction
    Date Received
    March 26, 1998
    Report Date
    March 1, 1998
    Manufacturer
    SUNRISE MEDICAL, INC.
    Product Code
    IMP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A NUMBER OF REPORTS OF "IN-USE" FAILURES WITH PRODUCTS MFG PRIOR TO FEBRUARY 1996 HAVE BEEN REC'D. THE REPORTED FAILURES RELATE TO THE FIXING SYS WHICH SECURE THE BACKREST TO THE WHEELCHAIR FRAME. FAILURE OF THESE FIXING SYS CAN LEAVE THE BACKRESTS INSECURE. ALL JAY CARE SUPPORTIVE BACKRESTS MFG BEFORE FEBRUARY 1996 SHOULD BE IDENTIFIED AND EXAMINED FOR INCORRECT FITTING OR VISIBLE SIGNS OF FAILURE IN THE AREA OF THE FIXING POINTS. (THOSE MFG PRIOR TO FEBRUARY 1996 DO NOT HAVE A HEXAGONAL NUT AT EACH END OF THE BOTTOM HARDWARE PINS). REMOVE FROM SVC BACKRESTS SHOWING ANY SIGNS OF FAILURE AND REPORT THESE FINDINGS TO THE MFR. THE FAILURES INCLUDE: FRACTURE OF THE MOUNTING BRACKETS, FRACTURE OF THE PLASTIC MOUNTING BLOCKS AND MOUNTING PINS COMING ADRIFT. SOME OF THE PROBLEMS MAY HAVE BEEN DUE TO THE UNITS NOT BEING FITTED CORRECTLY. THE MFR HAS INTRODUCED DESIGN CHANGES TO THE PRODUCT IN RESPONSE TO THE REPORTED PROBLEMS. FITTING INSTRUCTIONS ARE ALSO UNDER REVIEW BY THE MFR. THE NECESSARY PARTS FOR THE UPRATING OF THE JAY CARE SUPPORTIVE BACKRESTS HAVE BEEN MADE AVAILABLE FREE OF CHARGE BY SUNRISE MEDICAL LTD TO THEIR DIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAY CARE SUPPORTIVE BACKREST WHEELCHAIR CUSHION IMP SUNRISE MEDICAL, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO WHEELCHAIR