BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI SKY

    MDR report key: 1111821 · Received August 14, 2008

    Report

    Report Number
    9681684-2008-00018
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Report Date
    August 12, 2008
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAXI SKY 600 WAS IN BAD CONDITION. THE PLASTIC CAB WAS DAMAGED AND CRACKED IN SEVERAL PLACES, THE CIRCUIT CONTACT BLADES WERE BENT, THE GROUND LOOP ON THE TROLLEY WAS CUT OFF OR BROKEN, ONE WHEEL OF THE TROLLEY WAS BROKEN, AND THE OTHERS HAD BEGUN TO SLIDE OFF THE PIN. THE UNIT WAS ORIGINALLY A 4-FUNCTION UNIT, BUT HAD BEEN MODIFIED INTO A 2-FUNCTION UNIT. THE GATE SYSTEM APPEARED TO BE IN GOOD CONDITION; NO DAMAGED WIRES OR INCORRECT OR MISSING CONNECTIONS; NO LOOSE SCREWS OR OBJECTS, NO TRACES OF FOREIGN OBJECTS INSIDE. NO SHORT CIRCUITS WERE FOUND ON THE MICROPROCESSOR. THE GATE SYSTEM OPERATED NORMALLY DURING THE TOTAL TESTING PERFORMED IN NORMAL INTENDED USE (FOUR FUNCTIONS). AS THE FAULT WAS UNABLE TO BE REPRODUCED IN THE LAB, NO CONCLUSION COULD BE FORMED.

    Description of Event or Problem · 1

    THE FACILITY REPORTS A SINGLE GATE OPENED WHEN THE TRACK WAS NOT ALIGNED DURING THE UTILIZATION OF THE CASSETTE. THE CASSETTE DID NOT FALL. THE MALFUNCTION HAPPENED WHEN THE CAREGIVER WAS MOVING THE LIFT TO PICK UP A PT. THE FACILITY WAS UNABLE TO DETERMINE THE EXACT DATE THE MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI SKY CEILING LIFT FSA BHM MEDICAL, INC. LDXXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1