BEUDAMED
    FDA Adverse Event Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2760595 · Received September 26, 2012

    Report

    Report Number
    1531186-2012-01025
    Date Received
    September 26, 2012
    Date of Event
    September 3, 2012
    Report Date
    October 10, 2012
    Manufacturer
    HENYI ENTERPRISE
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFR REPORT # 1531186-2012-01025 INDICATING THE MANUFACTURER AS UNKNOWN. THE CORRECT MANUFACTURER IS HEN YI ENTERPRISES.

    Description of Event or Problem · 1

    (B)(6) - THE CONSUMER STATED THAT THE 9805P HYDRAULIC LIFT DURING USE WAS LOWERING PRIOR TO BEING ENGAGED TO LOWER. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    (B)(6) - THE CONSUMER STATED THAT THE 9805P HYDRAULIC LIFT DURING USE WAS LOWERING PRIOR TO BEING ENGAGED TO LOWER. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 DA Other