BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXI MOVE

    MDR report key: 4931608 · Received July 20, 2015

    Report

    Report Number
    3007420694-2015-00136
    Event Type
    Death
    Date Received
    July 20, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 30, 2015
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS OF 2014 THAT NUMBER WAS DE ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED. INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE DURING THE PATIENT'S TRANSFER ONE LEG CLIP OF THE SLING CRACKED AND THE PATIENT FELL BACK HITTING HIS HEAD ON THE TABLE. SOME DAYS AFTER ARJOHUNTLEIGH WAS INFORMED THAT THE PATIENT DIED WITHOUT KNOWING WHETHER IT IS DUE TO THIS ACCIDENT OR NOT, DESPITE ON OUR BEST EFFORTS. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (CLIP BROKEN). THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE LOW AND STABLE. THE LIFT (MAXI MOVE) AND THE SLING WHICH WORK AS A SYSTEM WERE INSPECTED AND FOUND TO HAVE MALFUNCTIONED (NOT TO SPECIFICATION) WHEN THE EVENT TOOK PLACE. NO MALFUNCTIONS WERE INDICATED REGARDING THE MAXI MOVE LIFT BUT AN ON-SITE INSPECTION FOUND THE SLING FITTED WITH "BLACK KEYHOLE" CLIPS DATED ON (B)(6) 1997 AND ONE OF THE LEG CLIPS WAS FOUND TO BE CRACKED. THIS WAS CONFIRMED BY PICTURES OBTAINED OF THE INVOLVED SLING. PRODUCTION OF SLINGS WITH BLACK KEYHOLE CLIPS WAS SEIZED SOME TIME AGO (YEAR 1999). WE CAN STATE THAT THE SLING INVOLVED IN THE INCIDENT IS ABOUT 18 YEARS OLD. THEREFORE THIS SLING WAS SIGNIFICANTLY PAST ITS LIFETIME, IT SHOULD HAVE BEEN DISCARDED AND SHOULD NOT HAVE BEEN USED, FOR MANY YEARS. IT HAS BEEN ESTABLISHED THAT THE LIFT DEVICE (MAXI MOVE) AND THE CLIP SLING WERE BEING USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT AND AS A RESULT OF A USE ERROR CONTRIBUTED TO THE MALFUNCTION AND THE OUTCOME OF THE EVENT. WITHIN THE SCOPE OF A MANUFACTURER INVESTIGATION, WE COULD STOP HERE, AS THIS DEVICE CLEARLY WAS USED FAR BEYOND ITS INTENDED AND LABELED LIFETIME. HOWEVER AS SHOWN BELOW WE HAVE FOUND THAT: DESPITE THE DEVICE HAVING BEEN USED YEARS PASSED ITS LIFETIME, THIS DOES NOT APPEAR TO BE THE REASON FOR CLIP BREAKAGE; THE CLIP BREAKAGE IS FOUND MOST LIKELY DUE TO FURTHER OFF-LABEL USE NOT FOLLOWING THE WASHING AND DRYING INSTRUCTIONS. BASED ON THE INFORMATION RECEIVED REGARDING THE INCIDENT AND OUR PRODUCT KNOWLEDGE IT COMES FORWARD THAT WE SEE CLIP BREAKAGE OCCUR IN THREE GENERAL WAYS, FROM LEFT TO RIGHT, FROM TOP TO BOTTOM AND AT THE LOWER BAR (THE WEAKEST PART OF THE CLIP) ((B)(4)). A BREAKAGE HERE IS WHAT IS EXPECTED TO OCCUR WHEN A CLIP IS PINCHED WITH A FORCE MUCH HIGHER THAN THE FORCE IT WILL NORMALLY RECEIVE DURING USE. IN THIS EVENT, WE CAN CLEARLY (B)(4), THAT THE CLIP BROKE PARTIALLY FROM TOP TO BOTTOM. THIS OCCURS WHEN A CLIP IS BENT IN EG: A WASHING PRESS, WITH ENORMOUS FORCE, WHILE THE LEFT AND RIGHT SIDES OF THE CLIP ARE PUSHED ON. THE MAXI MOVE LIFT AND INSTRUCTIONS FOR USE CONTAIN THE CRUCIAL INFORMATION: THE USEFUL LIFE EXPECTANCY OF THE ARJO SLING IS APPROXIMATELY 2 YEARS; MECHANICAL PRESSURE - PRESSING OR ROLLING, DURING THE WASHING OR DRYING PROCEDURES IS NOT ALLOWED. FROM THIS EVALUATION IT WOULD APPEAR MOST LIKELY THAT THE EVENT WAS CAUSED BY THE USER NOT FOLLOWING THE IFU, DUE TO LACK OF AWARENESS OF THE IFU CONTENTS. NOTE THAT THE CUSTOMER WAS INTERVIEWED BY A LOCAL ARJOUNTLEIGH REPRESENTATIVE BUT COULD NOT PROVIDE ANY TRAINING DATES FOR STAFF. ARJOHUNTLEIGH SUGGESTS TO REMIND THE STAFF INVOLVED OF THE DEVICE LABELING, WITH SPECIAL ATTENTION TO CORRECT WASHING PROCEDURE AND PROPER SLING INSPECTION FOR AGE AND DAMAGES BEFORE EACH TRANSFER. THIS IS TO BE COMMUNICATED TO THE CUSTOMER. WE FIND THE COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES. WE ARE ONLY RECENTLY IN RECEIPT OF YOUR LETTER DATED JULY 25TH WITH REFERENCE 3007420694-2015-00136 AND WILL RESPOND TO IT BEFORE THE SUGGESTED DEADLINE. FOR INFORMATION ALREADY INCLUDED IN THIS REPORT, WE WILL REFER TO IT.

    Description of Event or Problem · 1

    ON (B)(6) 2015 IT WAS REPORTED BY THE FACILITY TO ARJOHUNTLEIGH THAT WHEN TRANSFERRING A PATIENT AGED (B)(6), A CLIP OF THE SLING CRACKED AND THE PATIENT FELL BACK. THE PATIENT HEAD HIT THE TABLE. BETWEEN THE INCIDENT ((B)(6) 2015) AND THE TECHNICIAN APPOINTMENT ((B)(6) 2015) THE PATIENT DIED WITHOUT KNOWING WHETHER IT IS DUE TO THIS ACCIDENT OR NOT. ARJOHUNTLEIGH REPRESENTATIVE CALLED THE HOSPITAL AND SPOKE TO MR PIN, BIOMEDICAL ENGINEER IN CHARGE OF THIS CASE, HE CONSIDERS THAT IS MEDICAL CONFIDENTIALITY. SO HE DIDN'T GIVE US THE DATE OF THE PATIENT'S DEATH OR ANYTHING ELSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468107 MAXI MOVE FSA ARJO HOSPITAL EQUIPMENT AB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death