BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 4223295 · Received November 4, 2014

    Report

    Report Number
    3008262382-2014-01833
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 15, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THE ACTUATOR SNAPPED WHILE THE PATIENT WAS IN THE UNIT. PROVIDER STATES NO INJURY ALLEGED. PROVIDER STATES THE PATIENT WEIGHED (B)(6) LBS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706482 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE REHABILITATION EQUIP RPS350-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other