BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE RELIANT 450 BATTERY-POWERED LIFT

    MDR report key: 19123808 · Received April 17, 2024

    Report

    Report Number
    9616091-2024-00005
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    January 22, 2024
    Report Date
    April 17, 2024
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE UNDERLYING CAUSE OF THE REPORTED EVENT SEEMS TO HAVE BEEN CAUSED BY THE PATIENT'S MOVEMENTS DURING THE TRANSFER AND NOT A MALFUNCTION OF THE LIFT. AT THIS TIME, IT HAS ONLY BEEN IDENTIFIED THAT THE PATIENT SUSTAINED A MINOR INJURY; HOWEVER, IT WAS NOTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EVALUATION. NOTE: THE MANUFACTURING LOCATION OF THE SUBJECT LIFT IS UNKNOWN. THE CURRENT MANUFACTURER IS INVAMEX, SO THEIR CFN NUMBER IS BEING USED FOR THE MDR FILING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 0

    A FACILITY ADMINISTRATOR REPORTED THAT THREE CNAS AND NURSE WERE TRANSFERRING A RESIDENT TO HIS BED USING AN RPL450 LIFT. DURING THE TRANSFER, THE RESIDENT BEGAN MOVING, TWISTING AND FLATTLING HIS ARMS, CAUSING THE LIFT TO TIP TO THE SIDE. THE RESIDENT WAS LOWERED TO THE FLOOR INSIDE THE SLING. A LICENSED NURSE ASSESSMENT REVEALED THE RESIDENT SUSTAINED A SKIN TEAR TO HIS LEFT ARM. NO OTHER INJURIES WERE IDENTIFIED. THE RESIDENT DENIED PAIN AT THAT TIME AND REQUESTED TO BE PLACED BACK IN BED. HE WAS MADE AS COMFORTABLE AS POSSIBLE WHERE HE WAS WHILE AWAITING EMS ARRIVAL FOR FURTHER EVALUATION. THE RESIDENT WAS SENT TO HOSPITAL FOR EVALUATION. A CALL TO THE HOSPITAL ER WAS MADE TO GET AN UPDATE ON THE RESIDENT'S CONDITION. THE RESIDENT WAS BEING ADMITTED FOR FURTHER EVALUATION. HOWEVER, AT THAT TIME, NO SIGNIFICANT INJURY HAD BEEN IDENTIFIED. NHA AND THE MAINTENANCE DIRECTOR ARRIVED TO THE FACILITY TO CONDUCT STAFF INTERVIEWS AND EVALUATE THE OCCURRENCE. IT WAS DECIDED TO REMOVE THE LIFT IMMEDIATELY FROM SERVICE UNTIL THE LIFT COULD BE PHYSICALLY INSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340262 INVACARE RELIANT 450 BATTERY-POWERED LIFT LIFT, PATIENT, NON-AC-POWERED FSA INVAMEX RPL450

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Hospitalization