BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C500

    MDR report key: 10534473 · Received September 15, 2020

    Report

    Report Number
    1221084-2020-00045
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 7, 2020
    Report Date
    February 5, 2021
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL'S INITIAL INSPECTION DETERMINED A SCREW, INTERNAL TO THE GEARBOX, HAD LOOSENED WHICH CAUSED AN INTERFERENCE WITHIN THE GEARBOX ASSEMBLY RESULTING IN A BINDING OF THE GEARING. PERMOBIL WAS UNABLE TO DETERMINE A ROOT CAUSE DURING THE INSPECTION, AND THEREFORE RETURNED AFFECTED COMPONENT TO THE SUPPLIER FOR A MORE THOROUGH ANALYSIS. THE SUPPLIERS INVESTIGATION CONCLUDED THERE WERE NO FINDINGS, OR ANY DEVIATIONS IDENTIFIED IN THE MANUFACTURING PROCESS AND TECHNICAL ROOT CAUSE REMAINS UNKNOWN. DURING INSPECTION OF THE DEFECTIVE COMPONENT, REPORTS CONCLUDED TO HAVE FOUND TRACES OF THREAD LOCK FLUID ON THE LOCKING SCREW, WHICH CONFIRMED AS HAVING BEEN APPLIED, AS REQUIRED, ACCORDING TO THE ASSEMBLY INSTRUCTION. THIS SCREW IS ALSO TIGHTENED WITH A TORQUE TOOL. PERMOBIL HAS CONCLUDED THE MOST PROBABLE CAUSE AS TO WHY THE SCREW LOST ITS POSITION IS THAT THE THREAD LOCK DID NOT ADHERE TO THE SURFACE AS IT SHOULD, AND THEREFORE THE SCREW VIBRATED LOOSE. AS AN IMPROVEMENT TO THE PROCESS, THE SUPPLIER AGREED TO IMPLEMENT FURTHER VALIDATION STEPS IN THEIR MANUFACTURING PROCESS AS A PREVENTIVE ACTION. IT SHOULD BE NOTED PERMOBIL HAS UTILIZED THIS SUPPLIER FOR APPROXIMATELY 15 YEARS WITHOUT ANY KNOWLEDGE OF A SIMILAR FAILURE. A RISK ASSESSMENT HAS BEEN PERFORMED AND UPDATED IN CONSIDERATION FOR THIS NEW FAULT. BASED ON COMPLAINTS DATA AND DRIVE UNITS IN THE MARKET, THE PROBABILITY OF OCCURRENCE HAS BEEN DETERMINED TO BE LOW AND RISK IS FOUND ACCEPTABLE. THIS FAILURE IS SEEN AS AN ISOLATED EVENT AND WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO PERMOBIL BELGIUM FOR EVALUATION. REPORTS PROVIDED CONFIRM THE RIGHT DRIVE MOTOR GEARBOX HAINVG CEASED, UNABLE TO ROTATE. AN INITIAL INSPECTION OF THE GEARBOX WAS PERFORMED BY PERMOBIL TECHNICIANS IN THE FIELD WITH REPORTS CLAIMING INDICATIONS OF BROKEN TEETH ON ONE OF THE GEARS THAT MAKE UP THE INTERNAL WORKINGS. REPORTS INDICATE A DETERMINATION FOR THE FAILURE COULD NOT BE ESTABLISHED AS THERE WEREN'T ANY APPARENT PHYSICAL DAMAGES TO THE GEARBOX ASSEMBLY, NOR REPORTS OF ABNORMAL OPERATION PRIOR TO THE EVENT OCCURENCE. PERMOBIL (B)(4) HAS REPLACED THE AFFECTED MOTOR/GEARBOX ASSEMBLY, AND THE WHEELCHAIR WAS RETURNED BACK TO THE END-USER. THE AFFECTED COMPONENT IS BEING SENT TO PERMOBIL AB FOR A MORE IN-DEPTH EVALUATION IN EFFORTS TO DETERMINE A ROOT CAUSE OF THIS REPORTED ANOMALY. IF UPON COMPLETION OF THE EVALUATION A DETERMINATION CAN BE REACHED, AND IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP/SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED AND DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING AS THE END-USER WAS DRIVING THE POWER WHEELCHAIR, THEY ALLEGED HAVING HEARD A NOISE FROM THE CHASSIS THAT WAS FOLLOWED BY THE RIGHT DRIVE MOTOR REPORTEDLY HAVING LOCKED UP. REPORTS CLAIM THE END USER LOST THEIR BALANCE, AND FELL OUT OF THE SEATING. INFORMATION RECEIVED CLAIMS THE END-USER WAS NOT INJURED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999466 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1