BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2666037 · Received July 24, 2012

    Report

    Report Number
    9616091-2012-00216
    Event Type
    Malfunction
    Date Received
    July 24, 2012
    Date of Event
    June 21, 2012
    Report Date
    July 23, 2012
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL RPA450-1, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS 9 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1078987 REV I (JUN-06) 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 PATIENT IS A (B)(6). THE PATIENT'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE FACILITIES TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. STAFF MEMBER OF (B)(6), A PREMIER PROVIDER OF WORKERS' COMPENSATION RISK SOLUTIONS, CALLED STATING THAT A CARETAKER AND A CO-WORKER AT A FACILITY, (B)(6), WERE LIFTING A PATIENT IN THE RPA450-1 LIFT WHEN THE LIFT ALLEGEDLY BROKE. THE LIFT ALLEGEDLY BROKE CAUSING THE CARETAKER TO SUSTAIN INJURY TO HER NECK, RIGHT ARM AND PAIN IN LOWER BACK. THE CARETAKER IS A (B)(6). THE CARETAKER WENT TO THE EMERGENCY ROOM. SHE HAD X-RAYS TAKEN AND SUSTAINED SPRAIN (NECK), CONTUSIONS AND MUSCULAR PAIN. SHE WAS PRESCRIBED PAIN MEDICATION - TRAMADOL AND NAPROXEN. SHE IS CURRENTLY ON LIGHT DUTY AND UNDERGOING PHYSICAL THERAPY. (B)(6) WAS ABLE TO CONFIRM THAT THERE WERE 2 CARETAKERS AVAILABLE DURING THE TRANSFER. THE INCIDENT REPORT INDICATED THAT THE LIFT "BROKE." HOWEVER, UPON FURTHER INVESTIGATION IT WAS FOUND THAT A BOLT CAME LOOSE, THE LIFT DID NOT BREAK. THE FACILITIES MAINTENANCE DIRECTOR CONFIRMED TIGHTENING THE BOLT AFTER THE INCIDENT. PAGE 41 OF THE OWNER'S MANUAL LISTS THE MAINTENANCE SAFETY INSPECTION CHECKLIST WHERE IT STATES TO CHECK ALL HARDWARE ON A MONTHLY BASIS.

    Description of Event or Problem · 1

    CARETAKER AT FACILITY WAS LIFTING PATIENT WHEN LIFT ALLEGEDLY BROKE. INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVAMEX RPA450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 28 Other