BEUDAMED
    FDA Adverse Event Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2673695 · Received July 30, 2012

    Report

    Report Number
    1525712-2012-01058
    Date Received
    July 30, 2012
    Report Date
    July 26, 2012
    Manufacturer
    UNKNOWN
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9805P, SERIAL NUMBER/DATE CODE AND AGE OF PRODUCT ARE UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1024492, WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER IS A (B)(6). THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CONSUMER CALLED STATING THAT THE 9805P HYDRAULIC LIFT DOES NOT OFFER BRAKES AND ALLEGES THAT THE LIFT ROLLS UNCONTROLLABLY WHEN WEIGHT IS APPLIED. THE LIFT COMES WITH A SWIVEL CASTER ASSEMBLY WITH BRAKE. THE OWNER'S MANUAL STATES A WARNING PERTAINING TO THE CASTERS ON PAGE 26, "ONLY OPERATE THIS LIFT WITH THE LEGS IN MAXIMUM OPEN POSITION AND LOCKED IN PLACE. THE BASE LEGS MUST BE LOCKED IN THE OPEN POSITION AT ALL TIMES FOR STABILITY AND PATIENT SAFETY WHEN LIFTING AND TRANSFERRING A PATIENT". IT IS UNKNOWN IF THE CONSUMER READ AND UNDERSTOOD THE OWNER'S MANUAL PERTAINING TO THE LEGS AND CASTERS. INVACARE CUSTOMER SERVICE PROVIDED THE CONSUMER WITH PART NUMBER 1110421, THE CASTER ASSEMBLY, SWIVEL W/ BRAKE (5"). NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CONSUMER CALLED STATING THAT THE 9805P HYDRAULIC LIFT DOES NOT OFFER ANY BRAKES. CONSUMER ALLEGES THAT THE LIFT ROLLS UNCONTROLLABLY WHEN WEIGHT IS APPLIED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA UNKNOWN 9805P

    Patients

    Seq Age Sex Outcome Treatment
    1 73 Other