BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS

    MDR report key: 1047163 · Received May 9, 2008

    Report

    Report Number
    1221538-2008-00002
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    August 17, 2007
    Report Date
    May 9, 2008
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    HST
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON RETURN, THE TOWER ASSEMBLY WAS FOUND TO HAVE THREE BENT RODS WITH ONE THAT WAS DIFFICULT TO RAISE WITH DRAG/INTERFERENCE. THE SIDE OPPOSITE OF THE DAMAGED ROD HAD A VISIBLY BENT HOOK, LIKELY FROM THE IMPACT OF THE TOWER FALLING OVER AT SOME POINT AND IMPACTING ON THE FLOOR. ENGINEERING ASSESSMENT, WHICH REQUIRED DISMANTLING THE UNIT, REVEALED FURTHER WEAR WHICH WAS ACCELERATED DUE TO CONTINUED USE AFTER BEING DAMAGED. THE LOWER GUIDE WAS WORN AWAY IN A DISTINCT WEAR PATTERN AND THE SPRINGS WERE WORN DUE TO USE AFTER THE IMPACT DAMAGE. SOMEONE AT THE CUSTOMER FACILITY PLACED AN "INTERNAL SAFETY CHECK" STICKER ON THE PRODUCT DATED 2007 (THE SAME MONTH AS THE EMPLOYEE INCIDENT.) IT IS UNCLEAR IF THE CHECK OCCURRED PRIOR TO OR AFTER THE INCIDENT (THE REPORTER WAS UNSURE.) IT IS ALSO UNKNOWN IF ANY WORK OR ALTERATION HAD BEEN CONDUCTED ON THE TOWER AT THE CUSTOMER'S FACILITY. ALLEN CAN NOT CLEARLY ATTRIBUTE AN INJURY TO THE DAMAGED RODS AND INTERNAL COMPONENTS, BUT THE UNIT WAS CLEARLY USED AFTER HEAVY DAMAGE WAS SUSTAINED - WHICH IS CONSISTENT WITH THE CUSTOMER'S REPORT.

    Description of Event or Problem · 1

    ALLEN MEDICAL WAS CONTACTED BY A CUSTOMER WITH A REPAIR REQUEST ON APRIL 11, 2008. DURING THE CONVERSATION, THE CUSTOMER MADE MENTION THAT THE UNIT WAS DAMAGED PRIOR TO A 2007 INJURY INCIDENT INVOLVING A FORMER EMPLOYEE. THERE HAD BEEN A LABOR/LEGAL DISPUTE WITH THE EMPLOYEE WHICH HAD RECENTLY BEEN RESOLVED AND THE UNIT WAS NOW AVAILABLE FOR REPAIR. THE FORMER EMPLOYEE CLAIMED A LOWER BACK INJURY RESULTED FROM THE ATTEMPTED OPERATION OF THE DAMAGED TOWER. (THE TOWER'S HEIGHT ADJUSTER'S REQUIRE USERS TO GRASP THE KNOB AND TO APPLY PRESSURE, PULLING UPWARD TO SET THE DESIRED HEIGHT FOR THE IV TOWER HOOKS.) IT WAS EITHER DURING THE MANIPULATION OF THE KNOB OR THE BENDING OVER TO REACH THE KNOB THAT CAUSE THE ALLEGED INJURY, THE HOSPITAL REPORTS. THE SEVERITY OF THE REPORTED BACK INJURY AND THE RECOVERY STATUS OF THE FORMER EMPLOYEE WERE UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS ALLEN EZ I.V. / IRRIGATION TOWER HST ALLEN MEDICAL SYSTEMS O-LPA-A2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other