BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXIMOVE (GLOUCESTER)

    MDR report key: 1914387 · Received November 18, 2010

    Report

    Report Number
    9611530-2010-00117
    Event Type
    Other
    Date Received
    November 18, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MFG BY ARJO HOSP EQUIPMENT (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSP EQUIPMENT (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, ARJOHUNTLEIGH INC., (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2010: IT WAS REPORTED BY THE CUSTOMER THAT THE SPREADER BAR CAME OFF WHILE A PT WAS BEING HOISTED IN THE BATHROOM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMOVE (GLOUCESTER) LIFT, PATIENT, AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB OTHER

    Patients

    Seq Age Sex Outcome Treatment
    1