BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 4091955 · Received September 16, 2014

    Report

    Report Number
    3008262382-2014-01074
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 26, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE PUMP LEVER BOLT IS BROKEN OFF. DEALER STATES THE LIFT WAS JUST SOLD (B)(6) 2013 AND HE WILL FAX A PROOF OF PURCHASE. ON (B)(6) 2014 THE PUMP WAS REPLACED OUT OF THE DEALER'S STOCK. ON ORDER (B)(4) THEY REPLACED THEIR STOCK ON (B)(6) 2014. NO RMA WAS DONE AT THAT TIME. WE WILL BRING BACK THAT DEFECTIVE ONE TODAY. WHEN THE BOLT BROKE THE CONSUMER WAS DROPPED BACK DOWN ON THE BED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572578 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE REHABILITATION EQUIP 9805P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other