BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F5 CORPUS VS

    MDR report key: 10460550 · Received August 27, 2020

    Report

    Report Number
    1221084-2020-00042
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    January 7, 2020
    Report Date
    August 27, 2020
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS RECEIVED CLAIM THE END-USER HAD SUSTAINED A FRACTURE TO THEIR TIBIA, BUT IT WAS UNKNOWN HOW THE INJURY WAS SUSTAINED OR IF THE INJURY WAS SUSTAINED DURING USE OF THE WHEELCHAIR. REPORTS PROVIDED CLAIM THE WHEELCHAIR HAS BEEN EVALUATED AND WAS FOUND TO BE OPERATING ACCORDING TO SPECIFICATION. IT WAS REPORTED THE END-USER HAS HEALTHCARE AIDS WHO SUPERVISE THE PATIENT AT HOME, AND THERE IS AN ACKNOWLEDGMENT AMONG THE AIDS THAT THE "STAND" FUNCTION ON THIS DEVICE SHOULD NOT BE USED. REPORTER IN THIS CASE STATED NO PARTIES COULD CONFIRM THE INJURY SUSTAINED WAS CAUSED AS A RESULT OF USING THE WHEELCHAIR OR USE OF THE STAND FUNCTION, BUT ONLY THAT SERIOUS INJURY SOMEHOW HAS OCCURRED AND WAS PRESUMED TO HAVE OCCURRED WHILE USING THE WHEELCHAIR. AS DEVICE WAS FOUND TO BE FULLY OPERATIONAL AND NO REPORTS OR CLAIMS WERE MADE OF THE DEVICE HAVING CONTRIBUTED TO THE EVENT, PERMOBIL IS UNABLE TO DETERMINE A ROOT CAUSE. THE REPORTER HAS SPECULATED IF THE INJURY WAS SUSTAINED WHILE OPERATING THE DEVICE, THE MOST PROBABLE CAUSE WOULD BE USE ERROR BY INADVERTENTLY ACTIVATING THE STAND FEATURE. IN EFFORT TO MITIGATE ANY ACCIDENTAL USE OF THE STAND FEATURE ON THE WHEELCHAIR, PERMOBIL HAS PROVIDED RECOMMENDATION AS TO HOW TO DISABLE THE STAND FUNCTION UNTIL END-USER IS APPROVED, BY THEIR PHYSICIAN, TO CONTINUE THE USE OF THE STAND FEATURE. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    PERMOBIL AB RECEIVED A REPORT OF THE END-USER HAVING SUSTAINED A SERIOUS INJURY CONSISTING OF A BROKEN LEG. REPORTER IN THIS CASE COULD NOT CONFIRM THE END-USER ACTUALLY SUSTAINED SERIOUS INJURY USING THE WHEELCHAIR, BUT ONLY THAT SERIOUS INJURY SOMEHOW HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923984 F5 CORPUS VS POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization