BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-LIFTER 4

    MDR report key: 1881860 · Received October 8, 2010

    Report

    Report Number
    9681684-2010-00042
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 8, 2010
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PER THE ON-SITE INSPECTION PERFORMED BY AN (B)(4) TECHNICIAN, LIFT DID NOT PRESENT APPARENT DEFECTS DESPITE THE FACT THAT THE HANGER BAR WAS DETACHED FROM THE BOOM. IT CAN BE NOTICED THAT THE PLASTIC COVER PART THAT COVERS THE ATTACHMENT POINT OF THE LOAD CELL TO THE HANGER BAR WAS STILL ATTACHED TO THE BOOM AS THE HANGER BAR AND LOAD CELL WERE COMPLETELY DETACHED. FROM THE INVESTIGATOR FINDINGS, THE FACILITY PUT THE LIFT OUT OF SERVICE THE DAY BEFORE THE INCIDENT HAPPENED DUE TO A CONCERN ABOUT A CRACKED CASING. IT WAS INSPECTED BY THE STAFF MAINTENANCE, WHO DURING THEIR INSPECTION DISMANTLED THE DEVICE FOR EVALUATION BEFORE REASSEMBLING AND DESIGNATING AS SAFE FOR USE. BASED ON THIS STATEMENT AND ON PREVIOUS INVESTIGATIONS, THE DETACHMENT OCCURRED BECAUSE THE SPRING PIN THAT ATTACHES THE HANGER BAR TO THE LOAD CELL WAS ONLY PASSED THROUGH THE LOAD CELL PLASTIC COVER, AND WOULD NOT HAVE SECURED THE HANGER BAR. THE HANGER BAR WITH SCALE IS SOLD AS IS AND MUST NOT BE DISMANTLED, AND THERE IS NO INDICATION EITHER IN THE MAINTENANCE OR OPERATING MANUALS THAT SUGGEST IT. SCALE AND HANGER BAR CAN BE DETACHED FROM THE BOOM OF THE LIFT BUT MUST STAY FIXED TOGETHER. IN ADDITION (AS PER THE MEDI-LIFTER 4 OPERATING AND PRODUCT CARE INSTRUCTION IN THE "CARE AND PREVENTIVE MAINTENANCE" SECTION), THE ATTACHMENT POINT OF THE HANGER BAR TO THE BOOM MUST BE INSPECTED IN THE FOLLOWING MANNER: "ENSURE THE SPRING PIN IS PROPERLY INSERTED INTO THE SPREADER BAR BLOCK. THE SPRING PIN MUST BE FULLY INSERTED AND BE FLUSH WITH EACH SIDE OF THE BLOCK." NO RELATION CAN BE ESTABLISHED BETWEEN THE CRACKED CASING AND THE INCIDENT, AS THIS PART IS JUST A CASING THAT COVERS THE ATTACHMENT POINTS OF THE HANGER BAR TO THE SCALE. A TREND REVIEW SHOWS THAT THERE ARE A VERY SMALL NUMBER OF OCCURRENCES WITHIN A 4-YEAR TIME EVALUATION, SO THE TREND IS STABLE AND LOW. THE RISK ANALYSIS OF THE MEDI-LIFTER 4 IDENTIFIES A SEVERE RISK FOR A LOAD CELL IF NOT FIXED CORRECTLY TO THE BOOM AFTER MAINTENANCE, IN THE CASE WHEN THE SPRING PIN IS ONLY PASSED THROUGH LOAD CELL COVER. THE RISK ANALYSIS ALSO STATES THAT A MODIFICATION MUST BE PERFORMED TO THE TECHNICAL MANUAL TO ADD A SECTION CONCERNING THE ASSEMBLY PROCEDURE FOR THE HANGER BAR WITH SCALE. THE MANUFACTURER STRONGLY RECOMMENDS RETRAINING OF STAFF MAINTENANCE ABOUT THE PROCEDURE FOR THE DISASSEMBLING OF THE HANGER BAR, AS WELL AS DOUBLE-CHECKING THE PRESENCE OF THE COTTER PIN IN EACH ATTACHMENT POINT.

    Description of Event or Problem · 1

    WHILE A RESIDENT WAS IN MID-TRANSFER BY TWO STAFF MEMBERS, THE LIFT COMPLETELY LET GO AND THE RESIDENT FELL APPROXIMATELY 3 FEET TO THE GROUND, STRADDLED BETWEEN THE LEGS OF THE LIFT. AFTER THE INCIDENT, RESIDENT WAS TAKEN TO THE EMERGENCY ROOM BUT WAS NOT KEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-LIFTER 4 LIFT, PATIENT, NON AC POWERED FSA BHM MEDICAL, INC. 87011101

    Patients

    Seq Age Sex Outcome Treatment
    1