BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRAULIC LIFT W/ADJ BASE 9153629360

    MDR report key: 4444250 · Received January 23, 2015

    Report

    Report Number
    1525712-2015-00621
    Event Type
    Injury
    Date Received
    January 23, 2015
    Date of Event
    October 5, 2012
    Report Date
    January 6, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - 01/22/2015 - - INITIAL MFG REPORT # 1525712-2014-07078 WAS SUBMITTED TO THE FDA ON (B)(4) 2014. ADDITIONAL INFORMATION WAS BEEN OBTAINED ON 01/06/2015 FOR THE REPORT BUT DUE TO INVACARE'S UPDATED TRACKWISE SYSTEM A NORMAL FOLLOW-UP REPORT COULD NOT BE TRANSMITTED THROUGH NORMAL CHANNELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SAFETY STRAP BECAME LOOSE ON A RHA450-1 PATIENT LIFT DURING TRANSFER CAUSING THE PATIENT TO FALL. UNSPECIFIED INJURY. THE INVACARE RHA450-1 PATIENT LIFT WAS BEING USED WITH A NON-INVACARE SLING. PAGE 7 OF THE OWNER MANUAL STATES A WARNING: "INVACARE PRODUCTS ARE SPECIFICALLY DESIGNED AND MANUFACTURED FOR USE IN CONJUNCTION WITH INVACARE ACCESSORIES. ACCESSORIES DESIGNED BY OTHER MANUFACTURERS HAVE NOT BEEN TESTED BY INVACARE AND ARE NOT RECOMMENDED FOR USE WITH INVACARE PRODUCTS". ALSO STATED, "INVACARE SLINGS AND PATIENT LIFT ACCESSORIES ARE SPECIFICALLY DESIGNED TO BE USED IN CONJUNCTION WITH INVACARE PATIENT LIFTS. SLINGS AND ACCESSORIES DESIGNED BY OTHER MANUFACTURERS ARE NOT TO BE UTILIZED AS A COMPONENT OF INVACARE¿S PATIENT LIFT SYSTEM". NEW INFORMATION OBTAINED ON 01/06/2015 - END USER SUSTAINED A BROKEN LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55259 HYDRAULIC LIFT W/ADJ BASE 9153629360 LIFT, PATIENT, NON-AC-POWERED FSA INVACARE TAYLOR STREET RHA450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R