BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5

    MDR report key: 15329226 · Received August 31, 2022

    Report

    Report Number
    1221084-2022-00016
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    July 28, 2022
    Report Date
    October 21, 2022
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    UDI-DI
    17330818229844
    PMA / PMN Number
    K143014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL RECEIVED REPORT OF THE END-USER HAVING TO BE ADMITTED INTO THE HOSPITAL DUE TO DEVELOPING A PRESSURE WOUND REQUIRING MEDICAL INTERVENTION TO ADDRESS. REPORTS CLAIM A COMPONENT ON THE DEVICE HAD MALFUNCTIONED WHICH WOULD NOT ALLOW THE END-USER TO MANIPULATE THE SEATING INTO A TILTED POSITION TO ALLOW FOR PRESSURE RELIEF. THE END-USER CONTINUED TO UTILIZE THE DEVICE IN THIS STATE UNTIL THE DAMAGED COMPONENT COULD BE REPLACED. DUE TO LOGISTICAL ISSUES, THE COMPONENT WAS NOT SHIPPED IN A TIMELY MANNER AND DUE TO THE INABILITY TO WEIGHT SHIFT, THE END-USER REPORTEDLY DEVELOPED A PRESSURE ULCER. AT THIS TIME PERMOBIL HAS NOT DETERMINED THE ROOT CAUSE FOR THE COMPONENT FAILURE BUT HAS DETERMINED THE FAILURE IN AND OF ITSELF WAS NOT THE CAUSE OF THE REPORTED ADVERSE EVENT. ONCE PERMOBIL HAS RECEIVED ANY NEW INFORMATION AS TO CAUSE OF FAILURE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    SERVICE PROVIDER REPORTS HAVING REPLACED THE AP UNIT, AND THE DEVICE HAS BEEN RETURNED TO THE END-USER WITH NO FURTHER REPORTED ISSUES. PROVIDER CLAIMS THE SUSPECT COMPONENT HAD BEEN DISCARDED AS THEY WERE UNAWARE THAT PERMOBIL WAS WANTING THE COMPONENT BACK FOR INSPECTION. PROVIDER DESCRIBED THE ISSUE AS BEING THAT OF THE INABILITY TO PERFORM A TILT OR ELEVATE WITH A 20CA SEAT LIFT ERROR (NODE IS REQUIRED BUT NOT PRESENT). WITH TESTIMONY RECEIVED FROM PROVIDER, PERMOBIL BELIEVES A FAILURE OCCURRED, BUT AS SUSPECT COMPONENT HAD BEEN DISCARDED PRIOR TO EVALUATION, PERMOBIL IS UNABLE CONFIRM ROOT CAUSE FOR FAILURE WITHOUT SPECULATION. IT IS PERMOBIL'S CONTENTION THAT THE REPORTED COMPONENT FAILURE IN AND OF ITSELF WAS NOT THE CAUSE OF THE ADVERSE EVENT, BUT RATHER THE END-USER CONTINUING USE OF THE DEVICE IN A DIMINISHED STATE WITHOUT THE ABILITY TO PERFORM ADEQUATE WEIGHT SHIFTS.

    Description of Event or Problem · 0

    RECEIVED REPORT CLAIMING DUE TO THE INABILITY TO REPLACE DEFECTIVE COMPONENT ON THE WHEELCHAIR IN A TIMELY MANNER, THE END-USER DEVELOPED A PRESSURE ULCER REQUIRING HOSPITALIZATION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088652 PERMOBIL F5 POWERED WHEELCHAIR ITI PERMOBIL INC. F5 N/A 17330818229844

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization