BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO Z

    MDR report key: 8601358 · Received May 10, 2019

    Report

    Report Number
    3032618-2019-00005
    Event Type
    Injury
    Date Received
    May 10, 2019
    Date of Event
    April 11, 2019
    Report Date
    May 10, 2019
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE REVIEWED THE DHR FOR THIS CHAIR, AND IT PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS, AND MET SPECIFICATIONS AS ORDERED BY THE DEALER WHEN IT LEFT THE FACILITY. THE DEALER AND/OR A THERAPIST MEASURE THE USER FOR A WHEELCHAIR. TISPORT AS THE MANUFACTURER BUILDS THE CHAIR BASED ON THE MEASUREMENTS PROVIDED TO US FROM THE DEALER AND/OR THERAPIST. ALL DOCUMENTATION AND SPECIFICATIONS FOR THE CHAIR WERE APPROPRIATELY DISSEMINATED TO THE HEALTH SPECIALIST WORKING WITH THE END USER. THE DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A COMPANY REPRESENTATIVE INSPECTED THE CHAIR ON SITE. THE INSPECTION REVEALED THAT THE SEAT BACK ANGLE HAD BEEN INCREASED BY ROUGHLY 19 DEGREES, AND THE SET LENGTH OF THE ANTI-TIPS HAD BEEN REDUCED BY AN INCH FROM THE ORIGINAL SPECIFICATIONS. BY INCREASING THE SEAT BACK ANGLE, THE CHAIR HOLDS THE END USER'S WEIGHT FURTHER BACK, WHICH INCREASES THE THERAPIST OF A BACKWARDS TIP. WITH THE ANTI-TIP LENGTH REDUCED, THE EFFECTIVENESS OF THE ANTI-TIPS IS COMPROMISED, ALLOWING THE CHAIR TO ROTATE OVER THE ANTI-TIPS IN A BACKWARD TIP EVENT. THE WHEELCHAIR CLOSET WORKER PRESENT AT THE TIME OF THE ADVERSE EVENT WAS CONSULTED ABOUT THE CONFIGURATION CONCERNS, AND WAS SHOWN HOW TO ADJUST THE ANTI-TIP ASSEMBLIES TO THEIR SPECIFIED POSITION. IF MORE INFORMATION IS PROVIDED THAT CHANGES THE CONCLUSIONS OF THE INVESTIGATION, A FOLLOW UP MEDWATCH FORM 3500A WILL BE FILED.

    Description of Event or Problem · 1

    PROVIDER ALLEGES THE PATIENT WAS ATTEMPTING TO PROPEL A MANUAL WHEELCHAIR DURING OUTPATIENT EVALUATION WHEN THE CHAIR TIPPED BACK AND THE PATIENT'S HEAD STRUCK THE GROUND. PEOPLE NEARBY REPORTED HEARING THE SNAP OF BONE, AND THE END USER ALLEGEDLY STATE HE THOUGHT HE BROKE HIS NECK AGAIN. WE HAVE BEEN IN CONTACT WITH THE WHEELCHAIR CLOSET SINSE THIS INCIDENT, BUT WE HAVE NOT BEEN PROVIDED ANY ADDITIONAL INFORMATION ABOUT THE INJURY, OTHER THAN THESE ALLEGATIONS, AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394049 AERO Z WHEELCHAIR IOR TISPORT, LLC AERO Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization