BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F3

    MDR report key: 15013195 · Received July 14, 2022

    Report

    Report Number
    1221084-2022-00012
    Event Type
    Injury
    Date Received
    July 14, 2022
    Date of Event
    May 31, 2022
    Report Date
    July 14, 2022
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTS PROVIDED CLAIM ONE OF THE 2 BACKPACK HOOKS MOUNTED TO THE BACK REST OF THE WHEELCHAIR HAD BROKEN ALLOWING THE BACKPACK HOLDING 2 ENTERAL FEEDING PUMPS TO FALL TO THE GROUND. REPORTS CLAIM THE FEEDING TUBE WAS ATTACHED TO THE END-USER AT THE TIME AND WITH THE BACKPACK FALLING, YANKED THE FEEDING TUBE OUT OF THE END-USER'S STOMA RESULTING IN AN UNDISCLOSED INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS. PHOTO EVIDENCE CONFIRMED THE FAILURE OF THE ALUMINUM HOOK HAVING BROKEN JUST BELOW WHERE IT PROTRUDES FROM THE MOUNTING PLATE. PHOTOS PROVIDED ALSO APPEAR TO INDICATE THE BACKPACK WAS ONLY BEING HELD BY 1 HOOK AT A TIME AS OPPOSED TO EVENLY DISTRIBUTING THE WEIGHT OF THE BACKPACK. FURTHER REVIEW OF PHOTOS INDICATES THE REMAINING HOOK IS DISTENDED AND BENT WHICH WOULD INDICATE EXCESSIVE WEIGHT BEING APPLIED OR PHYSICAL DAMAGES HAVING BEEN APPLIED DUE TO IMPACTS. PERMOBIL HAS RECOMMENDED THE HOOKS BE REPLACED WITH NEW AND INSTRUCTION PROVIDED OF THE NEED TO EVENLY DISTRIBUTE THE WEIGHT BY USING BOTH HOOKS. PERMOBIL HAS NO RECORDED HISTORY OF THIS TYPE OF FAILURE MODE HAVING BEEN REPORTED BUT WILL CONTINUE TO MONITOR THROUGH TREND ANALYSIS. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED REPORT CLAIMING AS THE END-USER CAME TO A QUICK STOP WHILE DRIVING THEIR POWER WHEELCHAIR, ONE OF THE BACKPACK HOOKS MOUNTED ON TO THE BACK REST BROKE ALLOWING THE BACKPACK TO FALL TO THE GROUND. REPORTS INDICATE THE BACKPACK CONTAINED ENTERAL FEEDING PUMPS INSIDE AND WHEN THE BACKPACK FELL THE TUBE CONNECTED TO THE END-USER WAS PULLED FROM THEIR STOMA REQUIRING MEDICAL INTERVENTION TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062064 PERMOBIL F3 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F3 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization