BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMOVE (GLOUCESTER)

    MDR report key: 2758196 · Received August 28, 2012

    Report

    Report Number
    9611530-2012-00156
    Event Type
    Malfunction
    Date Received
    August 28, 2012
    Date of Event
    August 4, 2012
    Report Date
    August 6, 2012
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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 ARJO MED (B)(4). ADD'L INFO WILL BE PROVIDED UPON COMPLETION OF THE MFR'S INVESTIGATION. THE EVAL OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MFG AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE AJRO MED (B)(4). AS OF 06/15/2010, 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 HOSPITAL EQUIPMENT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIFT STRAPS OF THE MAXIMOVE BROKE DURING TRANSFER, THE PT DROPPED BUT DID NOT HIT THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMOVE (GLOUCESTER) PASSIVE FLOOR LIFTS FSA ARJO MED AB LTD. KRA0300

    Patients

    Seq Age Sex Outcome Treatment
    1