BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2843130 · Received November 21, 2012

    Report

    Report Number
    3004493922-2012-00497
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 23, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER REVIEW IT HAS BEEN DETERMINED THAT THIS IS A NON REPORTABLE EVENT. THE PUMP NOT HOLDING PRESSURE ON A 9805 HYDRAULIC LIFT WAS DETECTED DURING ASSEMBLY, THERE WAS NO USER INVOLVEMENT WITH THIS PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9805, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 9 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1024492, REV.E(MAY-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 CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. 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

    PUMP IS NOT HOLDING PRESSURE PER PROVIDER. NO INJURY REPORTED. IF ANY FURTHER INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other