BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI SKY 440

    MDR report key: 2223467 · Received June 17, 2011

    Report

    Report Number
    9681684-2011-00048
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON-SITE INSPECTION WAS PERFORMED BY AN ARJOHUNTLEIGH TECH AFTER THE INCIDENT. SINCE THE FACILITY APPEARED UNSURE WHICH DEVICE WAS INVOLVED IN THE EVENT, AND THEY HAVE TWO MAXI SKY 440 IN THEIR POSSESSION, HE INSPECTED BOTH UNITS AT THE FACILITY AND DEEMED THEM FIT FOR SVC, AS THEY DID NOT APPEAR TO HAVE ANY DEFECTS AND WERE STILL FUNCTIONING WELL. THE CARERS INVOLVED IN THE EVENT CONFIRMED THAT AFTER THE INCIDENT, THEY FOUND THE D-SHACKLE AND THE SPLIT RING ON THE FLOOR. UPON EXAMINATION OF THE PICTURES PROVIDED, THE MFR COULD ESTABLISH THAT THE PART DESCRIBED AS A "D-SHACKLE" IS NOT A GENUINE ARJOHUNTLEIGH PART AND IS NOT RECOGNIZED AS BEING USED ON ANY PRODUCTS. THE MFR PERFORMED A VERIFICATION OF THE DEVICE HISTORY RECORD OF BOTH PORTABLE LIFTS AND IT DID NOT REVEALED ANY ANOMALIES. IT WAS ALSO SHOWED THE DEVICES WERE MANUFACTURED AND SHIPPED WITH THE ADEQUATE CARABINER, WHICH IS THE PROPER ATTACHMENT PART OF THESE PORTABLE LIFTS TO THE TRACK. DURING THE FACILITY INTERVIEW, IT WAS REPORTED THAT WHEN THE PRODUCTS WERE DELIVERED TO THE CUSTOMER, THEY DID NOT WANT TO USE THE 36 IN REACHER FROM THE MFR, BUT RATHER THEIR OWN SHORTER 60 CM DETACHABLE BARS. AN INSPECTION WAS ALSO PERFORMED BY A THIRD PARTY, A REP FROM THE WORKSAFE DEPT, WHICH BELONGS TO THE AUSTRALIAN GOVERNMENT. HE DETERMINED IT HAD BEEN A HUMAN ERROR WHERE A RING HAD NOT BEEN CORRECTLY ATTACHED TO LOCK THE BAR ON THE D-SHACKLE. IT AGREES WITH THE MFR ANALYSIS, WHICH EVALUATE THAT THE PART CALLED THE D-SHACKLE OPENED, MOST PROBABLY DUE TO A SPLIT RING NOT BEING SECURED, ALLOWING THE LOCKING PIN TO COME OFF AND THE LIFT STRAP TO FALL OFF THE D-SHACKLE, RESULTING IN THE PORTABLE CEILING LIFT FALLING DOWN. IT WAS ALSO CONCLUDED THAT BOTH THE REACHER AND D-SHACKLE ARE NOT GENUINE ARJOHUNTLEIGH PARTS. BASED ON THE FACTS GATHERED, THE MFR CONCLUDES THAT THE PORTABLE CEILING LIFT SEPARATED FROM THE TROLLEY BECAUSE OF THE USE OF AN INAPPROPRIATE PART. HOWEVER, THE MALFUNCTION WOULD NOT LIKELY HAVE OCCURRED IF THE DEVICE HAD BEEN USED IN ACCORDANCE WITH THE PORTABLE LIFT INSTRUCTIONS FOR USE WHICH STIPULATES "ARJOHUNTLEIGH STRONGLY ADVISES AND WARNS THAT TO AVOID INJURIES THAT CAN BE ATTRIBUTED TO THE USE OF INADEQUATE PARTS, ONLY PARTS DESIGNED BY ARJOHUNTLEIGH SHOULD BE USED ON EQUIPMENT AND OTHER APPLIANCES SUPPLIED BY ARJOHUNTLEIGH." THEREFORE, IT IS STRONGLY RECOMMENDED TO THE FACILITY TO INSPECT ALL ITS DEVICES TO MAKE SURE ONLY PARTS DESIGNED BY ARJOHUNTLEIGH ARE USED WITH ARJOHUNTLEIGH EQUIPMENT, AND TO REPLACE INADEQUATE PARTS WITH GENUINE ARJOHUNTLEIGH PARTS IF REQUIRED.

    Description of Event or Problem · 1

    WHILE A RESIDENT WAS BEING TRANSFERRED FROM BED TO TUB CHAIR BY TWO CARERS USING A PORTABLE CEILING LIFT, THE D-SHACKLE (PART OF THE LIFT ATTACHMENT TO THE TRACK) CAME LOOSE, CAUSING THE LIFT TO SEPARATE FROM THIS ATTACHMENT AND FELL TO THE FLOOR WITH THE RESIDENT. THE RESIDENT WAS SENT TO THE HOSPITAL TO BE THOROUGHLY CHECKED AND SUFFERED A SKIN TEAR ON HER LEFT ARM FROM INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI SKY 440 MANUFACTURED PORTABLE CASSETTES FNG BHM MEDICAL, INC. LE0004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other