BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI LITE

    MDR report key: 6820038 · Received August 25, 2017

    Report

    Report Number
    9681684-2017-00064
    Event Type
    Injury
    Date Received
    August 25, 2017
    Date of Event
    August 13, 2017
    Report Date
    September 29, 2017
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE ARJOHUNTLEIGH MAGOG INC. (REGISTRATION (B)(4)) ON BEHALF OF THE IMPORTER (B)(4) ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ON 2017-AUG-14 ARJOHUNTLEIGH HAS BECOME AWARE OF AN INCIDENT REPORTED BY (B)(6). IT WAS ALLEGED THAT DURING RESIDENT TRANSFER FROM WHEELCHAIR TO BED USING MAXI LITE PASSIVE FLOOR LIFT, THE LIFT STOPPED FUNCTIONING WHEN THE RESIDENT WAS BEING LOWERED ONTO THE BED. AN ASSISTING CAREGIVER DECIDED TO REMOVE THE RESIDENT FROM THE LIFT MANUALLY BY HIMSELF/HERSELF (WITHOUT UTILIZING AN EMERGENCY LOWERING FUNCTION INCORPORATED IN THE DEVICE). AFTER DETACHING THE SLING (SECURING AND HOLDING THE RESIDENT) FROM THE LIFT SPREADER BAR, THE RESIDENT STARTED TO SLID OUT OF THE SLING. AS CONSEQUENCE OF THIS ISSUE, THE RESIDENT'S KNEE WAS HURT. HE ALSO SUSTAINED NECK STRAIN AND WAS TAKEN TO THE HOSPITAL DUE TO A PANIC ATTACK AFTER THE INCIDENT AND FOR DIAGNOSTIC (COMPUTERIZED AXIAL TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING). THE INCIDENT IS CONSIDERED AS AN ISOLATED OCCURRENCE - NO INCIDENTS PRESENTING SIMILAR SEQUENCE OF EVENTS WITH THE USE OF THE ARJOHUNTLEIGH MAXI LITE PASSIVE FLOOR LIFT WERE REGISTERED IN THE PAST. AN ARJOHUNTLEIGH REPRESENTATIVE VISITED THE CUSTOMER FACILITY IN QUESTION AND INSPECTED THE LIFT, BATTERY PACKS AND SLING THAT WERE USED AT TIME OF THE EVENT. THE INSPECTION REVEALED THAT THE LOWERING FUNCTION WAS STOPPED DUE TO DISCHARGED BATTERY. FOLLOWING AN INTERVIEW CONDUCTED WITH THE CUSTOMER, IT TURNED OUT THAT HE WAS UNAWARE OF LIFT'S EMERGENCY LOWERING AND ANTI-CRUSH FUNCTIONS, WHICH WERE EXPLAINED TO HIM BY ARJOHUNTLEIGH REPRESENTATIVE DURING THE VISIT. THE EMERGENCY LOWERING FUNCTION ALLOWS THE BOOM (LIFTING ARM) TO BE LOWERED IN THE EVENT OF A MAIN CONTROL FAILURE. THIS SHALL BE ACTIVATED BY PULLING THE HANDLE UP AND HOLDING IT UNTIL THE RESIDENT'S OWN WEIGHT ENABLES THE MAST TO SLOWLY LOWER TO THE INTENDED POSITION. THE SPRING LOADED HANDLE, WHEN RELEASED, STOPS THE LOWERING PROCESS. THE MAXI LITE HAS BEEN ERGONOMICALLY DESIGNED WITH BOTH THE CAREGIVER'S AND RESIDENT'S/PATIENT'S NEEDS IN MIND. THE DEVICE IS EQUIPPED WITH SAFETY FEATURES (SUCH AS THE MENTIONED ABOVE EMERGENCY LOWERING SYSTEM) TO PROVIDE SAFE AND COMFORTABLE TRANSFERS. IN THIS EVENT, THE OPERATOR OF THE DEVICE REMOVED THE RESIDENT (WHO WAS SAFE SUITED IN THE SLING) MANUALLY, INSTEAD OF UTILIZING THE EMERGENCY LOWERING FUNCTION AS PER THE RECOMMENDATIONS INCLUDED IN THE INSTRUCTION FOR USE (001.23104.EN REV. 6 FROM MAR 2014). THIS POSED A PATIENT AND CAREGIVER AT RISK. AS PER THE IFU, IT IS RECOMMENDED ALSO THAT A FULLY CHARGED BATTERY BACK ALWAYS BE AVAILABLE: "TO ENSURE THAT THE MAXI LITE IS ALWAYS READY FOR USE, IT IS RECOMMENDED THAT A FULLY CHARGED BATTERY PACK ALWAYS BE AVAILABLE. DO THIS BY HAVING ADDITIONAL BATTERY PACKS, AND KEEPING ONE BATTERY PACK CHARGING WHILE OTHER IS IN USE." FROM CUSTOMER INDICATIONS AND OUR INVESTIGATIONS THAT THERE WAS A MANUAL RELEASE FROM THE DEVICE BY AN OPERATOR THAT DOES NOT APPEAR TO HAVE HAD KNOWLEDGE OF HOW TO CORRECTLY USE THE DEVICE, WHICH OPENS THE DOOR TO THE POTENTIAL FOR PATIENT HARM. FROM THESE FINDINGS, THE DEVICE PLAYED A ROLE IN THE REPORTABLE EVENT WHILE IT WAS BEING USED WITH A PATIENT - NOT DUE TO A MALFUNCTION AS WAS SUGGESTED BUT DUE TO THE CUSTOMER / USER NOT FOLLOWING THE INSTRUCTIONS FOR USE WHICH PUT THE PATIENT IN THE RISKY SITUATION. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES BASED ON THE OUTCOME REPORTED - SOME SORT OF MEDICAL INTERVENTION WAS NEEDED.

    Description of Event or Problem · 1

    THE RESIDENT WAS BEING TRANSFERRED FROM WHEELCHAIR TO BED WITH MAXI LITE PASSIVE FLOOR LIFT. IT THE PROCESS OF BEING LOWERED, THE LIFT STOPPED WORKING. THE RAISING FUNCTION OF THE DEVICE WAS NOT FUNCTIONAL EITHER. A CAREGIVER TRIED TO REMOVE THE SLING BY HIMSELF/HERSELF. AT THAT MOMENT, THE RESIDENT SLIPPED OUT OF THE SLING. AS A CONSEQUENCE, THE RESIDENT'S RIGHT LEG / KNEE AND ALSO NECK WAS STRAINED. THE PATIENT WAS ADMITTED TO A HOSPITAL FOR DIAGNOSTIC IMAGING AND A 'PANIC ATTACK' POST EVENT OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600058 MAXI LITE NON-AC-POWERED PATIENT LIFT FSA ARJOHUNTLEIGH MAGOG INC. KM601001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R