BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER HML 400

    MDR report key: 2240850 · Received August 8, 2011

    Report

    Report Number
    2182305-2011-00020
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    June 28, 2011
    Report Date
    August 2, 2011
    Manufacturer
    APEX HEALTHCARE MFG INC
    Product Code
    FNG
    Removal / Correction Number
    Z-0904-06
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN UNDER RECALL SINCE 2006. THREE NOTICES HAVE BEEN SENT TO DEALER WITHOUT RESPONSE. PURSUANT TO THIS COMPLAINT, AN ADDITIONAL NOTICE WAS SENT TO THE DEALER, NO FOLLOW-UP HAS BEEN RECEIVED AND THE DEALER HAS NOT RETURNED THE DEVICE IN QUESTION FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER BY FACILITY, PER DEALER, A CUSTOMER NOTIFIED THE DEALER OF AN EVENT WITH A POSSIBLE INJURY OCCURRING ON (B)(6) 2011. THE DEALER, A HOMECARE RENTAL FACILITY, STATED ON HML 400 HYDRAULIC LIFT THEY HAD RENTED FAILED WHEN THE BOTTOM BOLT CAME OUT CAUSING THE JACK TO COME OFF THE MAST BRACKET; THE BOOM AND CRADLE FELL WITH A PERSON IN THE SLING. THE DEALER REPORTED THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM. NO OTHER INFORMATION HAS BEEN PROVIDED REGARDING AN INJURY. THE DEALER STATED HE WAS ADVISED BY HIS INSURANCE CARRIER TO REFRAIN FROM CONTACTING THE FAMILY, AS SUCH, INSUFFICIENT INFORMATION HAS BEEN OBTAINED BY THE MANUFACTURER AND IT IS UNKNOWN IF THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM FOR CAUSE PRECAUTION. PRELIMINARY INVESTIGATION REVEALS WHAT FAILED WAS THE JACK ON THE LIFT; THE SERIAL NUMBER (B)(4) OF THE LIFT WAS IN AN EARLIER RECALL Z-0904-06. MFR CONFIRMED RECALL DOCUMENTS WERE SENT TO DEALER THAT RENTED THE DEVICE TO HOME USER; HOWEVER, THE DEALER DID NOT FOLLOW THROUGH WITH THEIR RECALL RESPONSIBILITIES. THE DEALER HAS THE LIFT IN QUESTION AND HAS NOT RETURNED IT FOR EVALUATION. RECALL LITERATURE PROVIDED TO DEALER FOR FOURTH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER HML 400 PATIENT LIFT FNG APEX HEALTHCARE MFG INC HML 400

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other