BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CI HEALTHCARE

    MDR report key: 2000037 · Received February 18, 2011

    Report

    Report Number
    1034275-2011-00001
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    August 1, 2010
    Report Date
    February 17, 2011
    Manufacturer
    CI HEALTHCARE
    Product Code
    FPO
    Removal / Correction Number
    1034275-2/17/11-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE DETERMINED THE ROOT CAUSE OF THE PROBLEM WAS DUE TO AN INCORRECT MEASUREMENT FROM THE ORIGINAL DESIGN SAMPLE OF THE STRETCHERS WELDED HOOKS LOCATED ON THE STRETCHERS FRAME. THIS INCORRECT MEASUREMENT LED TO THE POSITIONING OF THE STRETCHERS WELDED HOODS, MEANT TO SECURE THE BACKREST SUPPORT BAR, TO BE ONE INCH SHORTER THAN THE ORIGINAL SAMPLE, AS PROVIDED BY THE DISTRIBUTOR. THE ONE INCH DIFFERENCE IN POSITIONING PRODUCES AN ANGLE ON THE BACKREST THAT COMPROMISES THE BACKREST SUPPORT BAR WHEN POSITIONED IN THE FIRST WELDED HOOK, CAUSING THE BACKREST SUPPORT BAR TO BEND SLIGHTLY WHEN WEIGHT IS APPLIED TO THE BACKREST (FOWLER). THE RESULT FROM THIS IS THE FOWLER FALLING AN APPROXIMATE DISTANCE OF 8 1/2" TO A FLAT POSITION. PRODUCT WAS CEASED ON (B)(6) 2010, AFTER RECEIVING THE COMPLAINT. REPAIR KITS CONSISTING OF A LONGER BACKREST SUPPORT BAR MEASURING 16 1/2" IN LENGTH WERE ORDERED FROM MANUFACTURER ON (B)(6) 2010, TO CORRECT THE EXISTING 72 UNITS IN COMMERCE. AN E-MAIL WAS RECEIVED ON (B)(6) 2010, FROM THE DISTRIBUTOR STATING THE INITIAL REPAIR KIT CORRECTED THE PROBLEM. IT HAS BEEN DETERMINED THAT TO PREVENT RECURRENCE OF THE MALFUNCTION, THE CURRENT DESIGN, WHICH FEATURES A 16 1/2" BACKREST SUPPORT BAR AND WELDED HOOKS POSITIONED AT 2 1/4" FROM STRETCHER FRAME, MUST BE CHANGED BACK TO THE ORIGINAL DESIGN, AS SPECIFIED BY DISTRIBUTOR, WHICH FEATURES A 15 1/2" BACKREST SUPPORT BAR AND WELDED HOOKS POSITIONED AT 3 1/4".

    Description of Event or Problem · 1

    A COMPLAINT WAS ISSUED ON (B)(6) 2010, BY THE DISTRIBUTOR OF THE PRODUCT IN QUESTION, INDICATING THAT THE PRODUCT PRESENTED A MALFUNCTION WHEN WEIGHT WAS APPLIED TO THE BACKREST (FOWLER), CAUSING THE BACKREST TO FALL TO A FLAT POSITION. THE INITIAL COMPLAINT MENTIONED 3 ISOLATED CASES, HOWEVER THE ENTIRE LOT OF THE 72 UNITS PRESENTED THE MALFUNCTION WHEN FURTHER TESTING WAS CONDUCTED BY THE DISTRIBUTOR. SERIAL NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CI HEALTHCARE GENERAL HOSPITAL STRETCHER, WHEELED FPO CI HEALTHCARE CI-8092 002

    Patients

    Seq Age Sex Outcome Treatment
    1