BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINSTREL (INCL. MINERVA)

    MDR report key: 2824176 · Received October 26, 2012

    Report

    Report Number
    3007420694-2012-00053
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 4, 2012
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE MEDIBO MEDICAL PRODUCTS (B)(4). AS OF (B)(4) 2012, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MFR. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH (B)(4). A COMPLETE INVESTIGATION WAS PERFORMED BY THE MFR INCLUDING A REVIEW OF THE TREND OF THIS AND SIMILAR PROBLEMS, HISTORY OF THE PRODUCT INVOLVED AND INVESTIGATION INTO THE REPORTED DEFICIENCY. FROM THE COMPLAINT REVIEW ONLY ONE EVENT ((B)(4) FOR MINSTREL WITH SCALE) MIGHT BE RELATED TO THE CURRENT ONE (SIMILAR FAILURE MODE), AND THAT THE CURRENT EVENT INVESTIGATION HERE IS NOT PART OF AN ONGOING TREND, NOR DOES IT SHOW THAT THE PREVIOUS FIELD ACTIONS FAILED TO ADDRESS THEIR INDIVIDUAL ISSUES. A HANGER BAR DROP WAS REPORTED. THE BOLT HOLDING THE HANGER BAR UNSCREWED COMPLETELY FROM THE LIFT ARM, WHICH IS SUGGESTING THAT THE SECURING PIN WAS NOT IN PLACE. THERE IS NO EVIDENCE OF MAINTENANCE OF THIS DEVICE IN THE CURRENT YEAR. ARJOHUNTLEIGH HAS NO SERVICE CONTRACT WITH THIS CUSTOMER. THE DEVICE RELATED WITH THIS EVENT IS MORE THAN 10 YEARS OLD. THE INSTRUCTION FOR USE THAT CAME WITH THE DEVICE, (B)(4) ISSUE 1, CLEARLY STATES: ¿THE EXPECTED OPERATIONAL LIFE OF THE MINSTREL IS TEN YEARS, PROVIDING IT HAS BEEN REGULARLY SERVICED AND MAINTAINED AS RECOMMENDED IN THESE INSTRUCTIONS.¿ ADDITIONALLY THE CUSTOMER WAS INFORMED VIA (B)(4) REV. 2 TO MAKE SURE THAT ALL DEVICES HAVE A PREVENTATIVE MAINTENANCE PLAN IN PLACE AND THAT THIS PLAN IS CARRIED OUT BY A COMPETENT ENGINEER USING THE LATEST ARJOHUNTLEIGH SERVICE PROCEDURES. NO BOLT BREAKAGE WAS REPORTED, BUT RATHER THE INDICATION THAT THE HANGER BAR HAS UNSCREWED ITSELF. THIS IS POSSIBLE IF THE LOCKING MEASURES THAT ARE PRESENT (INDUSTRIAL LOCTIE GLUE AND LOCKING PIN) ARE NOT ALL IN PLACE. NOTE THAT AFTER THE MISSING SECURING PIN, THE LOCKING FUNCTION OF THE INDUSTRIAL GLUE MUST BE OVERCOME, AND SUBSEQUENTLY THE LIFT HANGER BAR MUST BE TURNED A NUMBER OF TIMES BEFORE THE BOLT THREAD IS CLEARED ENOUGH FOR THE HANGER BAR TO FALL OUT. THIS IS NOT LIKELY TO HAPPEN IN A SHORT PERIOD BUT RATHER IS LIKELY TO TAKE A LONG PERIOD OF TIME, AT LEAST SEVERAL DAYS. THE IFU IS STATING: CARE OF YOUR MINSTREL, (P15) ¿THE FOLLOWING CHECKS SHOULD BE CARRIED OUT DAILY: [¿] WARNING: CHECK THAT ALL EXTERNAL FITTINGS ARE SECURE AND THAT ALL SCREWS AND NUTS ARE TIGHT.¿ FROM THE ABOVE WE COME TO THE ROOT CAUSE OF THE FACILITY NOT FOLLOWING THE DEVICE LABELING. NO TRAINING DATE COULD BE GIVEN FOR THE STAFF INVOLVED IN THE EVENT.

    Description of Event or Problem · 1

    ACCORDING TO COMPANY REP DESCRIPTION: DURING THE TRANSFER OF THE PT BETWEEN BED AND CHAIR THE SPREADER BAR FELL DOWN ON THE FLOOR WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINSTREL (INCL. MINERVA) PASSIVE FLOOR LIFTS FSA MEDIBO MEDICAL PRODUCTS NV HMB001-EU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization