BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOLERO

    MDR report key: 1531423 · Received November 11, 2009

    Report

    Report Number
    9611530-2009-00066
    Event Type
    Other
    Date Received
    November 11, 2009
    Date of Event
    October 14, 2009
    Report Date
    October 26, 2009
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER CONCLUDES THE ROOT CAUSE FOR THE EVENT IS USER ERROR. THE USER OF THE DEVICE HAS NOT FOLLOWED THE PROPER PROCEDURE FOR LOWERING THE DEVICE INTO THE BATH. IT IS STATED ON PAGE 9 IN THE OPERATING AND DAILY MAINTENANCE INSTRUCTIONS (4.22.01/1 GB, FEBRUARY 1993): "ALWAYS MAKE SURE THAT THE PT HOLDS HER ARMS ACROSS HER BODY THE MOMENT THE LIFT TROLLEY OR BATH TUB IS RAISED OR LOWERED." IN THIS CASE, THE PT HAD HER ARMS OUTSIDE OF THE STRETCHER AND GOT JAMMED BETWEEN THE STRETCHER AND THE BATH. THIS COULD HAVE RESULTED IN A BROKEN ARM; THEREFORE, THIS EVENT IS CONSIDERED TO BE REPORTABLE. THE MANUFACTURER RECOMMENDS THE CUSTOMER BE RETRAINED AGAINST THE PROPER HANDLING PROCEDURES IN THE OPERATING AND DAILY MAINTENANCE INSTRUCTIONS. EVEN THOUGH, IN THIS CASE, THE EXPECTED LIFETIME HAS NOT BEEN SPECIFIED, THE MANUFACTURER NOW CONSIDERS THE EXPECTED LIFETIME OF THIS TYPE OF DEVICE TO BE 10 YEARS. IT IS RECOMMENDED THAT CONSIDERATION IS GIVEN TO REPLACE THE ENTIRE DEVICE DUE TO ITS AGE (16 YEARS).

    Description of Event or Problem · 1

    THE FACILITY REPORTS WHEN LIFTING THE PT FROM THE BATH STRETCHER INTO THE WATER, THE CARER SAW THAT THE ARM OF THE PT GOT JAMMED BETWEEN THE SIDE RACK OF THE BATH STRETCHER. DURING LIFTING OF THE BATH STRETCHER INTO THE BATH, THE INJURY OCCURRED AND THE ARM GOT JAMMED BETWEEN THE BATH AND THE SIDE RACK. WHEN THE INJURIES WERE NOTICED, THE PT REMAINED AT THE SAME HEIGHT SO THE INJURY COULD BE LOOKED AT. THE ARM WAS FREED AND THE NURSING DONE. AFTER THIS, THE PT WAS CLOTHED ON THE BED. THE PT SUSTAINED A GRAZE TO THE RIGHT FOREARM. AN ARJOHUNTLEIGH INVESTIGATOR EXAMINED THE DEVICE AND FOUND THAT IT WAS 16 YEARS OLD. THE CONDITION WAS MODERATE; THE SERVICE CONTRACT HAD CONCLUDED. ALL FUNCTIONS CONFORMED TO MANUFACTURER SPECIFICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOLERO LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB 218100-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Other