BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL C500

    MDR report key: 8629028 · Received May 21, 2019

    Report

    Report Number
    1221084-2019-00018
    Event Type
    Death
    Date Received
    May 21, 2019
    Date of Event
    January 11, 2019
    Report Date
    June 6, 2019
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL GERMANY RECEIVED CONFIRMATION THE FOOTPLATE SUPPORT WHEEL ASSEMBLY HAD BEEN PHYSICALLY REMOVED FROM THE DEVICE AND WAS NOT INSTALLED AT THE TIME OF THE EVENT. THE SUPPORT WHEEL ASSEMBLY IS DESIGNED TO SUPPORT THE DEVICE WHEN WHEN THE SEATING SYSTEM IS PLACED INTO A STANDING POSITION. PERMOBIL GERMANY CONFIRMED AND PROVIDED PHOTO EVIDENCE DEPICTING THE DEVICE HAVING THE SUPPORT WHEELS INSTALLED PRIOR TO SHIPPING THE DEVICE TO THE SERVICE PROVIDER. PHOTOS TAKEN OF THE DEVICE AFTER THE REPORTED EVENT CLEARLY DEPICT THE SUPPORT WHEEL ASSEMBLY HAVING BEEN REMOVED. THIS CONFIRMATION HELPS SUPPORT INITIAL REPORTS OF THE END-USER HAVING INSTRUCTED THE DRIVER TO REMOVE THE SUPPORT WHEEL ASSEMBLY. IT WAS REPORTED TO PERMOBIL THAT THE END-USER HAS BEEN INSTRUCTED ON NUMEROUS OCCASIONS TO REFRAIN FROM HAVING THE SUPPORT WHEELS REMOVED DUE TO CONCERNS FOR USER SAFETY. IT WAS REPORTED EACH TIME THE END-USER REFUSED TO HEED THESE INSTRUCTIONS AS THEY ALLEGED THE SUPPORT WHEEL ASSEMBLY HINDERED ACCESS TO THEIR MOTOR VEHICLE. NO REPORTS OR ALLEGATIONS OF A DEVICE MALFUNCTION HAVE BEEN PLACED.

    Additional Manufacturer Narrative · 1

    PERMOBIL (B)(4) RECEIVED A REPORT CLAIMING THE END-USER WAS UTILIZING THE STAND FUNCTION OF THEIR DEVICE, IT ALLEGEDLY FELL FORWARD AND OVER WITH THE END-USER REMAINING IN THE SEATING. REPORT INDICATED THE END-USER WAS INITIALLY PICKED UP OFF THE FLOOR AND PUT INTO BED. THEREAFTER THE LOCAL RESCUE SERVICE WAS CALLED AND END-USER WAS TRANSPORTED TO THE HOSPITAL FOR UNDISCLOSED REASONS. REPORT CLAIMS THE END-USER SUBSEQUENTLY DECEASED APPROXIMATELY 3 MONTHS AFTER THE REPORTED INCIDENT WHILE REMAINING IN THE HOSPITAL. AT THIS STAGE IN THE INVESTIGATION, PERMOBIL DOES NOT HAVE ANY DETAILS AS TO THE EXTENT OF INJURIES SUSTAINED OR IF THE ACCIDENT WAS DIRECTLY OR INDIRECTLY THE CAUSE OF DEATH. THE INITIAL REPORT SUBMITTED TO THE (B)(6) AND PERMOBIL INDICATED THE END-USER HAD INSTRUCTED HER DRIVER TO REMOVE THE FOOTPLATE SUPPORT WHEELS FROM THE DEVICE AS THEY IMPEADED THE DEVICE FROM FITTING INTO HER MOTOR VEHICLE. AS THE DEVICE IS CURRENTLY IN THE CUSTODY OF THE POLICE, PERMOBIL IS UNABLE TO CONFIRM IF THIS UNAUTHORIZED MODIFICATION WAS PERFORMED. PERMOBIL WILL CONTINUE TO INVESTIGATE AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE RECEIPT OF NEW INFORMATION. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION, WITH SUPPORT WHEELS, PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT STATING WHILE END-USER WAS IN A STOOD POSITION PERFORMING EXERCISES, THE DEVICE ALLEGEDLY TIPPED FORWARD CAUSING THE END-USER AND SEATING TO FALL FORWARD TO THE GROUND. REPORTS INDICATE THE END-USER SUFFERED AN UNDISCLOSED INJURY FROM THE FALL REQUIRING HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419981 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H