BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL M300

    MDR report key: 6675239 · Received June 28, 2017

    Report

    Report Number
    1221084-2017-00036
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    May 31, 2017
    Report Date
    June 28, 2017
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS RECEIVED FROM SERVICE PROVIDER IS THE END-USER LIVES IN A MORE RURAL, FARM STYLE SETTING. PHOTOS SUPPLIED BY THE SERVICE PROVIDER ELUDE TO THE UNIT HAVING BEEN WELL USED, BUT NOT TO THE POINT OF ABUSE. REVIEW OF DHR SHOWN THE FRICTION BRAKE KIT, THAT SECURES THE CASTER FORK ASSEMBLY TO THE SUSPENSION, HAD BEEN ORDERED BY THE SERVICE PROVIDER APPROXIMATELY 1 YEAR PRIOR. PERMOBIL IS SPECULATING THE HARDWARE LOOSENED DUE TO POSSIBLE IMPROPER SERVICE COMBINED WITH LACK OF MAINTENANCE. PERMOBIL IS UNABLE TO POSITIVELY DETERMINE THE ROOT CAUSE AS TO HOW/WHY THE FASTENING HARDWARE LOOSENED. REPAIR PARTS HAVE BEEN SENT TO THE SERVICE PROVIDER. PERMOBIL REPRESENTATIVE WILL ACCOMPANY SERVICE PROVIDER TO ENSURE SERVICE IS PERFORMED TO SPECIFICATION. AFFECTED COMPONENTS WILL BE RETURNED TO PERMOBIL FOR INSPECTION. IF AFTER INSPECTION OF THE RETURNED COMPONENTS IT IS DETERMINED A PRODUCT FAILURE WAS THE ROOT CAUSE, A FOLLOW-UP MDR WILL BE FILED. THE DHR WAS REVIEWED AND UNIT WAS BUILT ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT ONE OF THE CASTER FORKS FELL OFF CAUSING END-USER TO FALL OUT OF THE CHAIR. REPORTS NO SERIOUS INJURY WAS SUSTAINED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453413 PERMOBIL M300 POWER WHEELCHAIR ITI PERMOBIL INC. M300 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1