BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL F5

    MDR report key: 10223247 · Received July 2, 2020

    Report

    Report Number
    1221084-2020-00028
    Event Type
    Malfunction
    Date Received
    July 2, 2020
    Date of Event
    May 19, 2020
    Report Date
    October 30, 2020
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED COMPONENT, AP UNIT, WAS RETURNED TO PERMOBIL FOR INSPECTION. EVALUATION CONFIRMED THE REPORT OF UNINTENTIONAL MOVEMENT OF THE REAR ACTUATOR WHEN THE DEVICE WAS POWERED ON. VISUAL INSPECTION OF THE REAR ACTUATOR SHOWN SIGNS OF PHYSICAL DAMAGES TO THE PLASTIC HOUSING OF THE INTERNAL CIRCUITRY HAVING BEEN SUSTAINED. INITIAL INSPECTION OF INTERNAL CIRCUITRY OF THE ACTUATOR DID NOT CLEARLY INDICATE ANY DAMAGE TO THE NAKED EYE, AND THE SUSPECT COMPONENT WAS SENT TO THE SUPPLIER FOR A MORE IN-DEPTH ANALYSIS. THE RESULTS OF ANALYSIS WERE FOUND AS BEING "MECHANICAL STRESS ON THE HOUSING HAS LED TO MECHANICAL AND ELECTRICAL DEFECT OF THE INTEGRATED CIRCUIT IC". PERMOBIL HAS DETERMINED THIS REPORTED FAILURE IS NOT THE RESULT OF A DESIGN OR MANUFACTURING DEVIATION, BUT A USE ISSUE CAUSING PHYSICAL DAMAGES FROM IMPACTS. PERMOBIL HAS INFORMED THE SERVICE PROVIDER OF THE FINDINGS AND HAS RECOMMENDED THEY RE-EDUCATE THE END-USER OF THE NEED TO BE MORE AWARE OF THEIR SURROUNDINGS IN EFFORT TO AVOID IMPACTS DURING USE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    PERMOBIL RECEIVED REPORT CLAIMING AS THE END-USER TURNED HIS CHAIR ON, A SEAT FUNCTION INITIATED WHICH CAUSED THE SEATING TO RAISE THE REAR OF THE SEAT PLACING THE SEATING INTO AN ANTERIOR TILTED POSITION. REPORTS INDICATE THE ONLY WAY TO STOP THE SEATING FROM OPERATING WAS TO TURN THE DEVICE OFF VIA THE JOYSTICK. REPORTS CLAIM EACH TIME THE DEVICE WAS TURNED ON, THE SEATING WOULD CONTINUE TO OPERATE WITHOUT COMMAND. IT WAS REPORTED THE SEATING PLACED THE END-USER IN A PRECARIOUS POSITION TO WHERE THEY WERE UP AGAINST A WALL BEING UNABLE TO EGRESS THE DEVICE REQUIRING THE NEED TO CONTACT EMERGENCY SERVICES IN ORDER TO REMOVE THE END-USER FROM THE SEATING AND INTO BED. NO INJURIES WERE REPORTED TO HAVE BEEN SUSTAINED AS A RESULT OF THIS REPORTED ANOMOLY. THE DEVICE WAS INSPECTED BY A PERMOBIL REPRESENTATIVE AND SERVICE PROVIDER WHO CONFIRMED THE REPORTED ISSUE. INITIAL EVALUATION COULD NOT DETERMINE THE ROOT CAUSE OF THIS REPORTED FAILURE. THE AFFECTED COMPONENT WAS REPLACED WITH NEW AND THE DEVICE OPERATIONALLY TESTED SATISFACTORY WITH NO FURTHER RECURRING ISSUES. THE AFFECTED COMPONENT IS BEING RETURNED TO PERMOBIL FOR FURTHER EVALUATION IN EFFORTS TO DETERMINE THE CAUSE OF THIS REPORTED FAILURE. UPON THE COMPLETION OF COMPONENT EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING AS END-USER POWERED UP THE WHEELCHAIR, THE SEATING IMMEDIATELY WENT INTO ANTERIOR TILT. THIS ACTION REPORTEDLY CAUSED THE END-USER TO BE PINNED AGAINST THE WALL REQUIRING A CALL TO 911 FOR ASSISTANCE TO EXTRACT CLIENT FROM THE DEVICE. NO INJURIES WERE REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686768 PERMOBIL F5 POWERED WHEELCHAIR ITI PERMOBIL INC. F5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1