BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOY-PRESENCE LIFT

    MDR report key: 3142454 · Received March 12, 2013

    Report

    Report Number
    3009402404-2013-00009
    Event Type
    Other
    Date Received
    March 12, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 8, 2013
    Manufacturer
    APEX HEALTHCARE MFG INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE FACILITY (B)(6) PER FACILITY THEIR NURSING STAFF WAS TRANSFERRING A RESIDENT FROM BED TO CHAIR. ABOUT 2" ABOVE THE CHAIR THE BOLT THAT ATTACHES THE SCALE TO THE CRADLE SNAPPED AND THE PT FELL INTO THE CHAIR. WHICH RESULTED IN THAT THE CRADLE HIT THE RESIDENT ON THE HEAD, NO REPORTABLE INJURIES TO THE RESIDENT [HAD A SCRATCH ON HIS HEAD AND WAS SHAKEN UP) BUT NO MEDICAL EVALUATION WAS DONE. AFTER FURTHER INVESTIGATION IT WAS REVEALED THAT THE UNIT WAS THE SAME UNIT INVOLVED IN THE S.I. [SAFETY INITIATIVE] PROGRAM WHICH SAID FACILITY DID NOT RESPOND TO. MANUFACTURER HAS SENT THREE NEW SCALE/CRADLE REPLACEMENT UNITS TO THIS FACILITY FOR THE THREE LIFTS THEY HAVE AND HAVE REQUESTED THE OLDER UNITS BE RETURNED TO US. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104980 HOY-PRESENCE LIFT PATIENT LIFTER FNG APEX HEALTHCARE MFG INC. HOY-PRESENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK