BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2726956 · Received September 5, 2012

    Report

    Report Number
    3004493922-2012-00313
    Event Type
    Malfunction
    Date Received
    September 5, 2012
    Report Date
    August 29, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL RPL600-2, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 11 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1145810 REV B (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 CONSUMER IS A (B)(4). 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 MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(6) AT FACILITY STATES: "HE RECEIVED A CALL BETWEEN 6 AND 7:30 PM FROM DIRECTOR OF NURSING WHO TOLD HIM THE STAFF WAS USING THE LIFT WITH A RLS600 SCALE AND WHEN THE STAFF LIFTED THE PATIENT ABOUT 6-7" OFF THE BED THE HANGER PORTION ALONG WITH THE SCALE CAME DETACHED OFF THE LIFT AND HIT THE PATIENT IN THE CHEST. (B)(6) IS THE DIRECTOR OF NURSING WHO GAVE (B)(6) THE INFORMATION. (B)(6) DID NOT HAVE NAY INFORMATION ON THE PATIENT AND SUGGESTED THAT WE CONTACT DIRECTOR OF NURSING 203-594-5325 TO GET MORE DETAILS. THE PATIENT WAS NOT HURT. SCALE IS IN BASEMENT, AND MARKED OUT OF SERVICE, DO NOT USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU RPL600-2

    Patients

    Seq Age Sex Outcome Treatment
    1 87 Other