BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C300

    MDR report key: 10375258 · Received August 6, 2020

    Report

    Report Number
    1221084-2020-00036
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 6, 2020
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS RECEIVED FROM THE END-USERS MOTHER ALLEGE ONE OF THE BOLTS THAT SECURE THE ARM PAD ASSEMBLY ON TO THE ARTICULATING HINGE BROKE AT THE ATTACHMENT POINT. WITH THIS FAILURE, IT WOULD CAUSE THE ARMREST TO NO LONGER PROVIDE SUPPORT. NO REPORT WAS MADE OF THE END-USER HAVING SUFFERED ANY INJURIES AS A RESULT OF THIS REPORTED FAILURE. REPORT PROVIDED CLAIMS THE END-USER FATHER REPAIRED THE DEVICE BY REPLACING THE DAMAGED BOLT WITH ONE PROCURRED AT THEIR LOCAL HARDWARE CENTER. THIS WAS REPORTEDLY PERFORMED IN ORDER FOR THE END-USER TO CONTINUE USE OF THE DEVICE. PERMOBIL RECOMMENDED THAT REPAIRS BE COMPLETED BY A PERMOBIL SERVICE PROVIDER AND THAT PERMOBIL APPROVED COMPONENTS BE USED. AS THE AFFECTED BOLT WAS DISCARDED, PERMOBIL IS UNABLE TO DETERMINE IF THERE WAS A DEVIATION WITH THE COMPONENT, BUT IS CONSIDERING THE FAILURE BEING RELATED TO EXCESSIVE STRESS LEADING TO THE EVENTUAL FATIGUE OF THE FASTENER. FAMILY HAS BEEN VERBALLY INSTRUCTED TO REFER TO THE PROVIDED USERS MANUAL WHERE IT CLEARLY OUTLINES THE ARMREST NOT TO BE USED AS A WEIGHT BEARING SURFACE. PERMOBIL PROVIDED THE LOCAL SERVICE PROVIDER WITH REPLACEMENT COMPONENTS IN ORDER TO REPAIR THE DEVICE ACCORDINGLY. THE DHR WAS REVIEWED AND CHAIR MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT OF RECURRING ISSUE OF HARDWARE ON ARMREST HAVING BROKEN WHICH ALLOWS THE ARMREST TO BECOME DETACHED FROM THE SEATING. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838420 PERMOBIL C300 POWERED WHEELCHAIR ITI PERMOBIL INC. C300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1