BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXILIFT

    MDR report key: 2110984 · Received April 1, 2011

    Report

    Report Number
    9611530-2011-00029
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MFG, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO MED. AB LTD (UNDER REGISTRATION (B)(4)). AS OF (B)(4) 2010, 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 ARJO HOSP EQUIPMENT AB, AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION (B)(4). AS OF THE DATE OF THIS REPORT, THE FACILITY HAS NOT ALLOWED AN ARJOHUNTLEIGH REP TO INSPECT THE DEVICE IN QUESTION. ARJOHUNTLEIGH WILL CONTINUE TO SEND REQUESTS TO THE FACILITY ABOUT ALLOWING A SERVICE TECH ON-SITE TO EVALUATE THE DEVICE. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    FACILITY INFORMED ARJOHUNTLEIGH THAT AN INCIDENT OCCURRED ON (B)(6) 2011 WHERE A PT WAS BEING LIFTED WITH A MAXILIFT. DURING THE TRANSFER, THE PT FELL AND HIT THEIR HEAD DUE TO A SLING DETACHMENT; FACILITY STATES THAT THIS WAS DUE TO THE CLIP NOT BEING FULLY ENGAGED. NO FURTHER INFO WAS GIVEN ABOUT ANY INJURIES SUFFERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXILIFT PASSIVE FLOOR LIFTS FSA ARJO MED AB LTD. 212000-06

    Patients

    Seq Age Sex Outcome Treatment
    1 Other