BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINSTREL (INCL. MINERVA)

    MDR report key: 2773857 · Received September 27, 2012

    Report

    Report Number
    3007420694-2012-00042
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    August 27, 2012
    Report Date
    August 28, 2012
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MFR MEDICAL PRODUCTS (B)(4). THE EVALUATION OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    INCIDENT DESCRIPTION ACCORDING TO THE SALES REPRESENTATIVE: TWO CAREGIVERS WERE TRANSFERRING THE RESIDENT FROM HER BED TO HER CHAIR AND HAD HOOKED UP THE SLING AND HAD RAISED THE RESIDENT OFF THE BED WHEN THEY HEARD A CLUCKING SOUND AND THE RESIDENT AND THE HANGER BAR FELL BACK ONTO THE BED. THE LIFTING MECHANISM DETACHED AND HIT THE RESIDENT IN THE LEFT HAND. THE CAREGIVER STATED THE MACHINE WOULD NOT RETRACT BACK TO THE LOW POSITION AND SUDDENLY IT WENT DOWN ON IT'S OWN. UPON INSPECTION, IT WAS NOTICED THAT THE BOLT HOLDING THE HANGER BAR AND SCALE BROKE OFF AND COMPLETELY CAME AWAY FROM THE LIFT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINSTREL (INCL. MINERVA) PASSIVE FLOOR LIFT FSA MEDIBO MEDICAL PRODUCTS NV HMA0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other