BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C500

    MDR report key: 9854642 · Received March 19, 2020

    Report

    Report Number
    1221084-2020-00015
    Event Type
    Injury
    Date Received
    March 19, 2020
    Date of Event
    February 14, 2020
    Report Date
    May 15, 2020
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION OF THE DEVICE SHOWN THE THREADED ROD PORTION OF THE LINK ARM (WHICH MAINTAINS THE ARMREST ANGLE) ON THE RIGHT SIDE ARMREST HAVING BROKEN WHERE IT ATTACHES TO THE ARMREST. THIS FAILURE ALLOWED THE ARMREST TO LOSE SUPPORT AND FALL DOWN. THE BROKEN ARMREST SCREW WAS SENT TO PERMOBIL AB FOR INVESTIGATION. THE END-USERS WEIGHT IS REPORTED TO BE APPROXIMATELY 70KG (154LBS) AND THE WHEELCHAIR IS EQUIPPED WITH 335MM (13IN) LONG ARMRESTS. INITIAL INSPECTION DID NOT INDICATE ANY SIGNS OF PHYSICAL DAMAGES HAVING BEEN SUSTAINED TO HAVE POTENTIALLY CONTRIBUTED TO THE BREAK. THE AFFECTED COMPONENT WAS SENT TO AN EXTERNAL, THIRD PARTY, COMPANY (KIWA INSPECTA) TO PERFORM MATERIAL ANALYSIS AND TENSILE PULL-TEST.THE DOCUMENTED RESULTS RECEIVED FROM KIWA INSPECTA CONCLUDED THE MATERIAL WAS WITHIN SPECIFICATION. FURTHER EVALUATION WAS PERFORMED BY PERMOBIL TECHNICAL ENGINEERING WHO DETERMINED THE FAILURE WAS THE RESULT MATERIAL FATIGUE. CALCULATIONS FOR FATIGUE FAILURE IN THE MATERIAL INDICATE THE USER WEIGHT COMBINED WITH ARMREST LENGTH SHOULD NOT CAUSED THIS FAILURE TO OCCUR UNDER NORMAL USE. PERMOBIL IS UNABLE TO DETERMINE THE ROOT CAUSE OF THIS FAILURE, BUT WILL CONTINUE TO MONITOR THROUGH TREND ANALYSIS. THE CORPUS 3G LR USER MANUAL, WHICH WAS PROVIDED WITH THE DEVICE, INDICATES SAFETY WARNINGS OUTLINING THE ARMREST AS NOT BEING INTENDED TO SUSTAIN HEAVY LOADS. THE END-USER HAS BEEN VERBALLY INSTRUCTED TO REFRAIN FROM USING THE ARMRESTS AS A WEIGHT BEARING SURFACE AND INFORMED TO REFERENCE THE USER MANUAL WHICH WAS PROVIDED TO THEM. THE DHR WAS REVIEWED AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    REPORT INDICATED AS THE END-USER WAS IN PROCESS OF DRESSING THEMSELVES, THEY WERE RESTING THEIR WEIGHT ON THE ARMREST OF THE SEATING FOR SUPPORT. DURING THIS PROCESS, IT WAS REPORTED THE ARMREST SUDDENLY GAVE WAY AND FELL DOWN FROM THE HORIZONTAL POSITION. THIS LOSS OF ARMREST POSITIONING REPORTEDLY CAUSED THE END-USER TO LOSE THEIR BALANCE AND FALL TO THE FLOOR. REPORTS INDICATE THE END-USER WAS TAKEN TO THE HOSPITAL WHERE THEY WERE DIAGNOSED AS HAVING SUFFERED FRACTURED TEETH AND VARIOUS LACERATIONS TO THEIR NOSE AND CHIN, SOME REQUIRING STITCHES TO REMEDY. INSPECTION OF THE DEVICE SHOWN THE THREADED ROD PORTION OF THE LINK ARM (WHICH MAINTAINS THE ARMREST ANGLE) ON THE RIGHT SIDE ARMREST HAVING BROKEN WHERE IT ATTACHES TO THE ARMREST. THIS FAILURE ALLOWED THE ARMREST TO LOSE SUPPORT AND FALL DOWN. THE CORPUS 3G USER MANUAL, WHICH WAS PROVIDED WITH THE DEVICE, INDICATES SAFETY WARNINGS OUTLINING THE ARMREST AS NOT BEING INTENDED TO SUSTAIN HEAVY LOADS. AT THIS POINT PERMOBIL IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE COMPONENT FAILURE. INVESTIGATION WILL CONTINUE AND UPON RECEIPT OF ANY NEW INFORMATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED AND THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING AS THE END-USER WAS LEANING ON THE ARMREST WHILE ATTEMPTING TO DRESS, THE RIGHT ARMREST WAS REPORTED TO HAVE FALLEN DOWN CAUSING THE END-USER TO LOSE BALANCE AND FALL TO THE FLOOR. THE FALL WAS REPORTED TO HAVE RESULTED IN AN INJURY REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318145 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization