BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2870931 · Received December 12, 2012

    Report

    Report Number
    3004493922-2012-00678
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED. UNDETERMINED ISSUE FOR HYDRAULIC PUMP FOR LIFT RHL450-1. INITIAL AWARENESS DATE (B)(6) 12, HOWEVER, NO DETERMINATION COULD BE MADE AT THAT TIME. MULTIPLE ATTEMPTS TO ACQUIRE ADDITIONAL INFORMATION TO MAKE THE DETERMINATION IF THE EVENT IS REPORTABLE OR NOT WERE UNSUCCESSFUL. THE LAST INQUIRY REQUEST WAS MADE ON (B)(6) 2012, THEREFORE, THE AWARENESS DATE HAS BEEN UPDATED TO (B)(6) 2012. NO NEW INFORMATION HAS BEEN RECEIVED AS OF THIS DATE. MDR FILED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. UNDETERMINED ISSUE FOR HYDRAULIC PUMP FOR LIFT RHL450-1. INITIAL AWARENESS DATE (B)(6) 2012, HOWEVER NO DETERMINATION COULD BE MADE AT THAT TIME. MULTIPLE ATTEMPTS TO ACQUIRE ADDITIONAL INFORMATION TO MAKE THE DETERMINATION IF THE EVENT IS REPORTABLE WERE UNSUCCESSFUL. THE LAST INQUIRY REQUEST WAS MADE ON (B)(6) 2012, THEREFORE, THE AWARENESS DATE HAS BEEN UPDATED TO (B)(6) 2012. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU RHL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other