BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINSTREL

    MDR report key: 2163482 · Received July 4, 2011

    Report

    Report Number
    3004468271-2011-00030
    Event Type
    Other
    Date Received
    July 4, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE MFG MEDIBO MEDICAL (B)(4). THIS WAS THE INITIAL USE OF THE SLING; IT IS UNK AT THIS TIME HOW LONG THE DEVICE HAS BEEN IN USE. THE CUSTOMER REPORTED THAT THE SLING BEING USED WAS SELECTED FOR THIS RESIDENT AFTER AN ASSESSMENT BY AN ARJOHUNTLEIGH SALES EXECUTIVE. ALTHOUGH AN INJURY DID NOT OCCUR, THE HOME PHYSIOTHERAPIST HAS JUDGED THAT THE SLING TYPE WAS INAPPROPRIATE FOR THE RESIDENT (THE SLING WAS MADE SPECIFICALLY FOR THE RESIDENT). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    TWO CARERS WERE HOISTING THE RESIDENT FROM BED TO WHEELCHAIR AND AS THE MINSTREL DEVICE WAS MOVED AWAY FROM THE BED TOWARDS THE CHAIR, THE RESIDENT FELL THROUGH THE APERTURE IN THE SLING TO THE FLOOR (THE DISTANCE WAS APPROX ONE METER). THE RESIDENT LANDED ON HER BOTTOM. CARERS USED A DIFFERENT SLING TO PICK HER UP FROM THE FLOOR AND PUT HER BACK INTO BED FOR MONITORING. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINSTREL PASSIVE FLOOR LIFT FSA MEDIBO MEDICAL PRODUCTS NV HMA0007

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other