BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2820001 · Received November 5, 2012

    Report

    Report Number
    9616091-2012-00491
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 14, 2012
    Report Date
    November 3, 2012
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL GRPL450-1, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1078987 REV. J (MAY-11) 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 MALE CONSUMER'S AGE IS (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. MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). THE CARETAKER STATED THE STRAP FROM SLING THAT GOES OVER THE RIGHT SHOULDER PULLED RIGHT OUT OF THE CANVAS. THE CONSUMER WASN'T INJURED AND IT HAPPENED WHILE HE WAS STILL IN THE BED. THE SLING HASN'T BEEN WASHED YET AND THEY ONLY USE THE SLING TO TAKE THE CONSUMER OUT OF THE BED TO GO INTO THE WHEELCHAIR AND BACK INTO THE BED. THE CARETAKER SAID THEY ARE ALSO HAVING ISSUES WITH THE LIFT NOT STOPPING WHEN IT'S GOING UP. IN ORDER FOR IT TO STOP, THEY HAD TO BANG THEIR HAND AGAINST IT. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVAMEX GRPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 64 Other