BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C500

    MDR report key: 7931519 · Received October 3, 2018

    Report

    Report Number
    1221084-2018-00059
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    August 25, 2018
    Report Date
    October 3, 2018
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO PERMOBIL (B)(4) FOR EVALUATION. INVESTIGATION REPORT CONCLUDED THE SENSOR FOR THE CO-PILOT WAS OUT OF ADJUSTMENT. VISUAL EXAMINATION SHOWN THE CO-PILOT HANDLE TO HAVE SOME SCUFF MARKS AND THE HANDLE WAS NOT IN THE NORMAL LEVEL POSITION NEEDED FOR NORMAL OPERATION. IT WAS ALSO NOTED THE BRACKET FOR THE CO-PILOT HAD A SLIGHT BEND INDICATING PRIOR IMPACTS HAVING OCCURRED. TEST OPERATION OF THE DEVICE WITH THE CO-PILOT IN THE STATE IN WHICH IT WAS RETURNED SHOWN WHEN FORCE WAS APPLIED TO THE CO-PILOT HANDLE BEFORE THE START UP SEQUENCE IS COMPLETE THE WHEELCHAIR CAN BECOME VERY DIFFICULT TO HANDLE. WITH THE CO-PILOT SENSOR BEING INCORRECTLY ADJUSTED, THE CHAIR WILL 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 CONCLUDED THAT CAUSE OF THE EVENT WAS DUE TO MISALIGNMENT OF THE SENSOR IN THE CO-PILOT HANDLE. IT REMAINS UNCLEAR IF THE MISALIGNMENT WAS CAUSED BY IMPROPER USE BY THE ATTENDANT AND/OR INADVERTENT IMPACTS TO THE CO-PILOT HANDLE WHICH FORCED THE SENSOR TO BECOME MISALIGNED. FOLLOW-UP INSTRUCTIONS WILL BE RELAYED TO THE CAREGIVERS AS TO THE PROPER POSITIONING AND OPERATION OF THE CO-PILOT. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT WHILE ATTENDANT WAS ATTEMPTING TO REPOSITION CHAIR WITH THE CO-PILOT CONTROL, THE CHAIR ALLEGEDLY ACCELERATED FORWARD DRIVING THE DEVICE INTO A REFRIGERATOR. REPORTS INDICATE END-USER SUSTAINED A MINOR INJURY TO THEIR FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771341 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization