BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABINA

    MDR report key: 2063370 · Received April 1, 2011

    Report

    Report Number
    8030916-2011-00016
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Removal / Correction Number
    Z-1692-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCAL DISTRIBUTOR REQUESTED REPLACEMENT PARTS AND CONFIRMED THE PARTS WERE INSTALLED ON THE LIFT. NO FURTHER INFO REGARDING THE DISCOVERY OF THE MISSING PARTS WAS SUPPLIED BY THE FACILITY STAFF.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED THAT ALLEGED THE SCREWS HAD FALLEN OUT OF THE HOOKS OF THE LIFT. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABINA NON-AC POWERED PATIENT LIFT FSA LIKO AB SABINA II EE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK