BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMOVE (GLOUCESTER)

    MDR report key: 1981080 · Received January 27, 2011

    Report

    Report Number
    9611530-2011-00010
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MFG BY ARJO HOSP EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSP EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN (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 2011-(B)(6): SLING (B)(4) XXL IS PLACED IN WHILE CLIENT IS IN BED, TIGHTENED ON THE MAXI MOVE IN LOW POSITION. PLACED THE WEIGHT UNIT AND WENT UP. BATTERY WAS LOW, LEFT THE CLIENT WAITING WHILE PICKING A NEW BATTERY, LIFT UP. STOP BETWEEN CHAIR AND BED TO WEIGH. AFTER THAT THE CLIENT FELL OUT OF THE LIFT WHILE TURNING TO THE CHAIR. SHE FELL BESIDE HER BED. DRY ENVIRONMENT - 20M2. CARER IS SHOCKED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1