BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXI MOVE

    MDR report key: 1848947 · Received September 14, 2010

    Report

    Report Number
    9611530-2010-00062
    Event Type
    Other
    Date Received
    September 14, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE REPORTING ACCORDING TO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2010: "DURING THE TRANSFER OF THE RESIDENT FROM THE BED, TWO OF THE STRAPS THAT HOLD THE CLIPS ON THE SLING TORE/SNAPPED. THE RESIDENT FELL ONTO THE BED AND WAS NOT INJURED. IN THE TECH'S FURTHER FINDINGS, IT IS STATED THAT THE WORN SLING WAS NOT AN ARJOHUNTLEIGH PRODUCT." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE LIFT, PATIENT, NON-AC POWERED FSA ARJO HOSPITAL EQUIPMENT AB KMBB4OLU2FUS

    Patients

    Seq Age Sex Outcome Treatment
    1