BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A-SERIES

    MDR report key: 10553540 · Received September 18, 2020

    Report

    Report Number
    3007802293-2020-00018
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    February 6, 2020
    Report Date
    December 21, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    A TECHNICIAN VISITED THE FACILITY ON 2020-02-07 AND REPLACED THE STRAP. THE ACCOUNT MANAGER WAS UNABLE TO OBTAIN ANY FURTHER INFORMATION ABOUT THIS INCIDENT. HOWEVER, UPON INVESTIGATION, IT WAS DISCOVERED THAT THIS IS A KNOWN POTENTIAL ISSUE WITH THE A-SERIES WHICH HAS BEEN OBSERVED INTERNALLY. NORMALLY, WHEN THE CARRY BAR NEARS THE TOP LIMIT, A MAGNETIC SENSOR ACTIVATES AND TRIGGERS THE MOTOR TO STOP. DURING UNLOADED OR LIGHT LOAD OPERATIONS, THE MOTOR CAN STOP QUICKLY. HOWEVER, IT HAS BEEN OBSERVED THAT WHEN THE LIFT IS LOADED TO NEAR ITS MAX CAPACITY (625 LBS.), THERE IS A POTENTIAL THAT ALTHOUGH THE MAGNETIC SENSOR TRIGGERS THE MOTOR TO STOP, THE INERTIA OF THE HIGH LOAD MASS MEANS THE MOTOR WILL TAKE LONGER TO STOP. THE MAGNETIC PATCH IN THE STRAP CAN THEN GET LODGED BETWEEN THE STRAP ROLLERS. TO REMOVE THE CARRY BAR FROM THIS SITUATION REQUIRES A LARGE AMOUNT OF FORCE AND WILL RESULT IN THE CARRY BAR SUDDENLY DROPPING DOWN ONCE IT IS FREE OF THE ROLLERS. THIS ISSUE IS DIFFICULT TO REPLICATE RELIABLY AND IS RELATED TO A COMBINATION OF WEIGHT, SPEED, BATTERY CHARGE LEVEL, AND ANGLE OF LIFTING. HOWEVER, IT IS A KNOWN POTENTIAL DESIGN ISSUE. NO CORRECTIVE ACTIONS ARE NEEDED AT THIS TIME. THIS IS AN INFREQUENT EVENT THAT CAN BE PREVENTED WITH CAREFUL HANDLING OF THE LIFT.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS ONGOING. FURTHER DETAILS WILL BE SUBMITTED WHEN AVAILABLE.

    Description of Event or Problem · 1

    A CARRY BAR BECAME LODGED IN THE HIGHEST POSITION AND WOULD NOT LOWER WHEN THE HANDSET WAS PRESSED, THOUGH THE EMPLOYEE COULD HEAR THE SOUND OF THE MOTOR UNSPOOLING. THE CARRY BAR THEN DROPPED ONTO THE HEAD OF THE EMPLOYEE, HITTING THE EMPLOYEE IN THE FACE (MOUTH, LIPS, TEETH, CHEEK AREA). THE EMPLOYEE LEFT WORK AND WENT TO HOSPITAL AND TOOK TIME OFF WORK AS A RESULT. HANDICARE WAS INFORMED OF THE INCIDENT ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019694 A-SERIES A-SERIES FSA HANDICARE USA INC. 324103

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization