BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2760134 · Received September 26, 2012

    Report

    Report Number
    3004493922-2012-00364
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 25, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9099, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 8 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1049388 REV C (JUN-00), WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. THIS PRODUCTS SERIAL NUMBER FALLS UNDER CAPA #(B)(4). IT IS A KNOWN ISSUE WITH INVACARE. IT IS UNKNOWN IF THIS IS AN OUT OF BOX FAILURE AT THE DEALER OR IF THIS PRODUCT ACTUALLY MADE IT INTO THE FIELD TO AN END USER. THE PRODUCT IS BEING RETURNED TO INVACARE FOR AN INSPECTION. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER CALLED STATING THAT THE 9099 HYDRAULIC PUMP FOR THE 9805 HYDRAULIC LIFT IS ALLEGEDLY LEAKING OIL. DEALER COULD NOT VERIFY IF THIS SERIAL NUMBERED PUMP WAS ONE OF THE OUT OF BOX FAILURES OF IF THE PRODUCT MADE IT INTO THE FIELD TO A USER. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU 9099

    Patients

    Seq Age Sex Outcome Treatment
    1 Other