BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C500

    MDR report key: 6886285 · Received September 22, 2017

    Report

    Report Number
    1221084-2017-00085
    Event Type
    Malfunction
    Date Received
    September 22, 2017
    Date of Event
    September 11, 2017
    Report Date
    October 20, 2017
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THAT THE ROOT CAUSE OF THIS FAILURE MODE IS CONNECTED TO "IMPROPER SERVICE / MAINTENANCE". PERMOBIL HAS EVALUATED THE WHEELCHAIR AND PERMOLOCK DOCKING SYSTEM INSTALLED IN THE PATIENT'S VEHICLE. THE WHEELCHAIR AND THE DOCKING SYSTEM WERE TESTED AND PASSED INSPECTION, OPERATING ACCORDING TO SPECIFICATION. HOWEVER, IT WAS DISCOVERED THAT THE CAR ADAPTION COMPANY IN THE COUNTRY OF NORWAY FAILED TO INSTALL THE DASHBOARD INDICATOR WHICH ALERTS THE END USER BY VISUAL INDICATION THAT SECURE DOCKING HAS OR HAS NOT OCCURRED. THE CAR ADAPTION COMPANY HAS BEEN NOTIFIED OF THIS DISCREPANCY AND WAS INFORMED TO ALWAYS INCLUDE THE DASHBOARD INDICATOR THAT IS SUPPLIED WITH THE PERMOLOCK SYSTEM. THE PATIENT HAVING ACKNOWLEDGED EXPERIENCING PAST PROBLEMS ENGAGING THE DOCKING SYSTEM BUT FAILED TO REPORT IT TO THE DEALER OR TO PERMOBIL. THE PATIENT HAS BEEN INFORMED THAT IF MALFUNCTION OR DAMAGES OCCUR TO STOP USING THE EQUIPMENT AND CONTACT PERMOBIL IMMEDIATELY; AND WAIT FOR CERTIFIED APPROVAL BEFORE CONTINUING USAGE. IT WAS DISCOVERED THAT THE PATIENT WAS NOT WEARING A POSITIONING BELT, AS REQUIRED WHEN OCCUPYING THE WHEELCHAIR. THE PATIENT HAD FAILED TO FOLLOW THE LABELS FOR INTENDED USE FOUND WITHIN THE OWNER'S MANUAL, ATTACHED TO REPORT. THE PATIENT IS NOW AWARE OF THESE SPECIFIC WARNINGS. DUE TO PERMOBIL'S ACCIDENT POLICY, THIS WHEELCHAIR CANNOT BE SUPPORTED HAVING BEEN IN SUCH AN EVENT. THE PATIENT WAS PROVIDED A LOANER WHEELCHAIR AND A NEW WHEELCHAIR ORDER IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DOCKING PROBLEMS PRIOR TO THIS INCIDENT. THERE IS NO EVIDENCE THAT THE PROBLEM WAS EVER REPORTED TO THE DEALER, VEHICLE MODIFICATION COMPANY OR TO PERMOBIL. WE ARE SEEKING TO UNDERSTAND MORE ABOUT THIS FAILURE MODE. UPON COMPLETION OF OUR INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED AND WILL INCLUDE ANY MISSING INFORMATION NOT FOUND IN THIS REPORT.

    Description of Event or Problem · 1

    REPORTS THAT PATIENT WAS DRIVING UP "(B)(6) ROAD" IN (B)(6) IN HER VEHICLE BY HERSELF, WHEN THE WHEELCHAIR DISENGAGED FROM THE PERMOLOCK DOCKING SYSTEM AND ROLLED BACKWARDS. THE VEHICLE LOST SPEED AND STOPPED DUE TO RUNNING IDLE. THE VEHICLE ROLLS BACKWARDS OFF THE ROAD AND DOWN A SMALL GRASSY HILL STOPPING ON THE LAWN. THE PATIENT FELL OUT OF THE WHEELCHAIR (NOT WEARING A POSITIONING BELT) AND WAS PINNED BETWEEN A PORTABLE WHEELCHAIR RAMP AND THE WHEELCHAIR ITSELF. THE PATIENT SUFFERED VARIOUS COMPLICATED FRACTURES THAT REQUIRED SURGERY (PELVIS, THIGHBONE, LEGS, ANKLES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667351 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization