BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 1221516 · Received November 5, 2008

    Report

    Report Number
    9611530-2008-00064
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    September 19, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFTER INVOLVED WAS INVESTIGATED ON-SITE, AND WAS FOUND TO BE WORKING TO OEM SPECIFICATIONS. NO ALLEGATIONS HAVE BEEN MADE WITH REGARD TO A TECHNICAL MALFUNCTIONING OF THE LIFT DEVICE. PICTURES OF THE SLING INVOLVED WERE SENT TO THE MANUFACTURER, WHICH SHOWED THE SLING TO BE IN AN ACCEPTABLE CONDITION. THE SLING WAS INDICATED TO BE AN EXTRA-LARGE SLING, WHICH APPEARS TO BE TOO BIG A SLING FOR THIS PATIENT. THE PATIENT'S CONDITION IS DESCRIBED AS "TOTALLY DEPENDANT"; NO INDICATION IS PRESENT THAT THE PATIENT IS PRONE TO OR HAS HAD SPASMS DURING TRANSFER. NO INDICATION WAS MADE IN THE CUSTOMER'S REPORT THAT THE CLIP BECAME DETACHED. RATHER, THE EVENT IS DESCRIBED AS "L[EFT SIDE LEG] STRAP WAS NOT LATCHED." BOTH THE LIFT DEVICE'S OPERATING AND PRODUCT CARE INSTRUCTIONS, AS WELL AS THE GUIDELINES FOR USE OF THE SLING CLEARLY STATE THAT, BEFORE LIFTING THE RESIDENT, THE CLIPS SHALL BE PUT IN PLACE AND THE CLIPS AND STRAPS SHALL BE UNDER TENSION. BASED ON THE INFORMATION GATHERED AND THE INVESTIGATION AND EVALUATION PERFORMED, THE MANUFACTURER CONCLUDES THE RESIDENT IN THIS INCIDENT DID NOT DROP OUT OF THE SLING AS A RESULT OF CLIP DETACHMENT, BUT FROM NON-ATTACHMENT. THE LIFT OPI AND SLING GUIDELINES CLEARLY INDICATE THE CORRECT PROCEDURES WHICH PREVENT THIS FROM OCCURRING. IT IS THE MANUFACTURER'S OPINION THAT THE ROOT CAUSE FOR THE EVENT IS A USER ERROR. THE CUSTOMER'S INCIDENT REPORT INDICATES THAT CARERS HAVE ALREADY BEEN REMINDED TO MAKE SURE THE CLIPS ARE IN PLACE. HOWEVER, THE MANUFACTURER STRONGLY ENDORSES THE FULL RE-TRAINING OF STAFF AGAINST THE LATEST OPI.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THEY WERE LIFTING THE RESIDENT OUT OF THE BED TO THE WHEELCHAIR. DURING THE TRANSFER, THE LEFT CLIP DETACHED, AND THE RESIDENT STARTED SLIDING DOWN. THE RESIDENT'S LEG BECAME STUCK ON THE LIFT AND STOPPED THE RESIDENT'S FALL. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE PATIENT LIFT FSA ARJO HOSPITAL EQUIPMENT AB KMBB4XXXXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1