BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C500 CORPUS 3G

    MDR report key: 8195904 · Received December 26, 2018

    Report

    Report Number
    1221084-2018-00081
    Event Type
    Injury
    Date Received
    December 26, 2018
    Date of Event
    June 8, 2018
    Report Date
    December 26, 2018
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL (B)(4) RECEIVED REPORT CLAIMING THE END-USER FELL OUT OF THE DEVICE AFTER AN ALLEGED SUDDEN STOPPAGE OF THE DEVICE. REPORTS INDICATE THE END-USER WAS NOT WEARING A POSITIONING BELT AT THE TIME OF THE REPORTED INCIDENT. REPORTS CLAIM WHEN THE DEVICE STOPPED, THE END-USER LOST POSITIONING AND FELL OUT TO THE DEVICE SEATING TO THE GROUND TO WHERE THEY LANDED ON THEIR RIGHT ELBOW AND LEG. IT WAS REPORTED THE END-USER WAS TAKEN TO THE HOSPITAL FOR EVALUATION TO WHERE THEY WERE DIAGNOSED AS SUFFERING A FRACTURE TO THEIR RIGHT FEMUR. IT WAS REPORTED THE DEVICE WAS FULLY INSPECTED BY SERVICE PROVIDER TECHNICIANS WHO STATED THERE WERE NO ISSUES FOUND WITH THE DEVICE. IT WAS REPORTED THE DEVICE WAS FULLY OPERATIONAL WITH NO DEVIATIONS BEING NOTED NOR SIGNS OF ANY PREVIOUS MALFUNCTIONS HAVING OCCURRED. PERMOBIL WAS INFORMED THE DEVICE HAD SINCE BEEN RE-ISSUED TO A DIFFERENT END-USER AND NO SERVICE RELATED ISSUES HAVE BEEN REPORTED SINCE RE-ISSUANCE. THE END-USER INVOLVED IN THIS REPORTED EVENT WAS PROVIDED A NEW DEVICE AND IS REPORTED TO HAVE RECOVERED FROM THEIR INJURIES. NOTE: PERMOBIL (B)(4) WAS NOT NOTIFIED OF THIS EVENT UNTIL 6 MONTHS AFTER OCCURRENCE DUE TO THE FACILITY FAILING TO INFORM UNTIL JUST RECENTLY. DUE TO THE 6-MONTH TIMESPAN AND THE DEVICE BEING UNAVAILABLE AFTER HAVING BEEN RE-ISSUED TO A DIFFERENT END-USER, PERMOBIL (B)(4) WAS UNABLE TO INSPECT THE DEVICE TO DETERMINE IF A DEVICE MALFUNCTION ATTRIBUTED TO THE ALLEGED SUDDEN STOPPAGE. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT WHILE END-USER WAS OPERATING THE DEVICE OUTDOORS, THE DEVICE ALLEGEDLY STOPPED SUDDENLY CAUSING THE END-USER TO LOSE POSITIONING AND FALL OUT OF THE SEATING TO THE GROUND. REPORTS INDICATE THE END-USER SUFFERED AN INJURY TO THEIR RIGHT LEG REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037211 PERMOBIL C500 CORPUS 3G POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization