BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F5 CORPUS VS

    MDR report key: 9722885 · Received February 18, 2020

    Report

    Report Number
    1221084-2020-00010
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 22, 2020
    Report Date
    April 30, 2020
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OVER THE COURSE OF THE INVESTIGATION, IT WAS BROUGHT TO PERMOBIL'S ATTENTION THE SERIAL NUMBER INITIALLY PROVIDED BY THE REPORTER, (B)(6), WAS INCORRECT. THIS FOLLOW-UP REPORT IS BEING SUBMITTED AS A CORRECTION TO PROPERLY IDENTIFY THE CORRECT DEVICE.

    Additional Manufacturer Narrative · 1

    THE SUSPECT COMPONENT WAS RETURNED TO PERMOBIL AB FOR EVALUATION. INVESTIGATION CONCLUDED THE SENSOR FOR THE CO-PILOT WAS OUT OF ADJUSTMENT. VISUAL EXAMINATION SHOWN THE HANDLE WAS NOT IN THE PROPER LEVEL POSITION NEEDED FOR NORMAL OPERATION. INTERVIEWS WITH SERVICE PERSONNEL INDICATE DURING THEIR INITIAL EVALUATION TO DETERMINE POTENTIAL ISSUE, THEY HAD MISALIGNED THE SENSOR PRIOR TO RETURNING TO PERMOBIL FOR INSPECTION. WITH THE CO-PILOT SENSOR BEING INCORRECTLY ADJUSTED, THE CHAIR MAY MANEUVER IN A DIRECTION THAT IS NOT DESIRED WHEN THE CO-PILOT IS ACTIVATED. AFTER REPOSITIONING THE SENSOR TO THE CORRECT POSITION, THE CO-PILOT CONTROL OPERATED AS PER DESIGN SPECIFICATION WITH NO NOTABLE ISSUES. PERMOBIL WAS UNABLE TO CONFIRM THE REPORTED EVENT WAS CAUSED DUE TO MISALIGNMENT OF THE SENSOR IN THE CO-PILOT HANDLE AS COMPONENT WAS REPORTEDLY ALTERED PRIOR TO INSPECTION. IT REMAINS UNCLEAR IF THE CO-PILOT CONTROL WAS MISALIGNED DURING USE BY THE ATTENDANT AND/OR INADVERTENT IMPACTS TO THE CO-PILOT HANDLE WHICH COULD POTENTIALLY FORCE THE SENSOR TO BECOME MISALIGNED. THE CO-PILOT CONTROL WAS REPLACED WITH NEW AND DEVICE RETURNED TO THE END-USER WITH NO FURTHER ISSUES BEING REPORTED. FOLLOW-UP INSTRUCTIONS HAVE BEEN RELAYED TO THE CAREGIVERS AS TO THE PROPER POSITIONING AND OPERATION OF THE CO-PILOT CONTROL. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING WHILE THE END-USER AND DEVICE WHERE INSIDE AN ELEVATOR, THE ATTENDANT ATTEMPTED TO BACK THE DEVICE UP VIA THE CO-PILOT ATTENDANT CONTROL. REPORTS CLAIM THE DEVICE DROVE FORWARD INSTEAD OF BACKWARD SUBSEQUENTLY RUNNING THE DEVICE INTO THE ELEVATOR WALL, PINCHING THE END-USERS FOOT. NO SERIOUS INJURIES TO THE END-USER WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184874 F5 CORPUS VS POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1