BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL C500

    MDR report key: 8025978 · Received October 31, 2018

    Report

    Report Number
    1221084-2018-00069
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    September 12, 2018
    Report Date
    December 14, 2018
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. THE WHEELCHAIR WAS BEING SERVICED AS A PART OF MAINTENANCE. DURING THE INITIAL WHEELCHAIR EVALUATION PERFORMED BY THE TECHNICIAN ON 9/12/2018, THE SEAT LIFT WAS IDENTIFIED TO BE LOOSELY MOUNTED TO THE CHASSIS. NO HARM HAS COME TO THE PATIENT AS PROBLEM WAS FOUND DURING SERVICE. THE TECHNICIAN THEN IDENTIFIED A DIFFERENT COMPONENT INSTALLED IN THE WHEELCHAIR AND REQUESTED FOR A COMPLAINT INVESTIGATION. NOTE: THE INFORMATION PROVIDED FROM SERVICE WAS INSUFFICIENT AND DEVICE PROBLEM COULD NOT BE CLASSIFIED AT THE TIME PERMOBIL WAS MADE AWARE. MULTIPLE ATTEMPTS WERE MADE TO COLLECT ADDITIONAL INFORMATION CONCERNING THIS WHEELCHAIR AND THE ALLEGED COMPLAINT WITH NO SUCCESS. AS OF TODAY, PHOTOS OF THE FAILURE WERE RECEIVED WITH CLEAR INDICATION THAT THE SUSPECT SEAT ELEVATOR (MFG. MARCH 2007, SERIAL NO. (B)(4)) WAS NOT THE ORIGINAL SEAT ELEVATOR (SERIAL NO. (B)(4)) INSTALLED ON THE WHEELCHAIR WHEN MANUFACTURED BY PERMOBIL ON APRIL 18, 2012. BASED UPON OUR ASSESSMENT, THE WHEELCHAIRS ORIGINAL SEAT ELEVATOR WAS REMOVED, AND THE SUSPECT SEAT ELEVATOR WAS THEN LATER INSTALLED BY AN UNKNOWN SOURCE (EXACT DATE OF THE INSTALLATION IS UNKNOWN). THE HEALTHCARE FACILITY WHO MAINTAINS THE WHEELCHAIR WAS MADE AWARE OF OUR FINDINGS. THE HEALTHCARE FACILITY REPORTED HAVING NEVER REPLACED THE SEAT ELEVATOR BEFORE. THEREFORE, COMPLAINT INVESTIGATION WILL CONTINUE. UPON COMPLETION OF THE MANUFACTURER'S EVALUATION A FOLLOW-UP REPORT WILL BE SUBMITTED AND WILL CONTAIN ANY MISSING INFORMATION THAT IS NOT DOCUMENTED IN THIS REPORT. THE DHR FOR THIS DEVICE HAS BEEN REVIEWED AND THE WHEELCHAIR MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THAT THE ROOT CAUSE OF THIS FAILURE MODE IS LINKED TO "IMPROPER SERVICE / MAINTENANCE" BY THE SERVICING DEALER. IN THE INITIAL REPORT, THE DEALER DID NOT SHOW ON RECORD ANY SERVICE WORK BEING DONE TO THE WHEELCHAIR. HOWEVER, LATER IT WAS DISCOVERED THAT THE DEALER DID PERFORM SERVICE IN 2014 BY INSTALLING THE SUSPECT COMPONENT IN THE WHEELCHAIR. THE REASON THE DEALER'S ORIGINAL RECORDS INDICATED NO SERVICE WAS PERFORMED IS BECAUSE THE DEALER DID NOT PURCHASE THE SEAT ELEVATOR DIRECTLY FROM PERMOBIL IN 2014 BUT HAD USED A SEAT ELEVATOR FROM THE DEALER INVENTORY. THE SERVICING DEALER HAS BEEN INFORMED OF OUR FINDINGS. THE DEALER WAS UNABLE TO DETERMINE WHOM HAD PERFORMED THIS IMPROPER SERVICE, AND THEREFORE, AGREED TO COVER THIS FAILURE MODE WILL ALL THE TECHNICIANS. THE SERVICING DEALER HAS BEEN SUPPLIED PROPER INSTRUCTION FOR INSTALLING THE SEAT ELEVATOR COMPONENT TO FACILITATE TRAINING. THE SUSPECT WHEELCHAIR HAVING PAST EXPECTED LIFE OF THE DEVICE HAS BEEN DISCARDED AND THE PATIENT IS GETTING A NEW REPLACEMENT WHEELCHAIR, SO NO ADDITIONAL CORRECTIONS TO THE SUSPECT DEVICE WILL BE SOUGHT. A CAPA HAS BEEN OPENED BY OUR PARENT COMPANY TO FURTHER INVESTIGATE THIS FAILURE MODE AND MONITOR EFFECTIVENESS. THE DHR FOR THIS DEVICE HAS BEEN REVIEWED AND THE WHEELCHAIR MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    THE WHEELCHAIR WAS IN FOR SERVICE AND THE TECHNICIAN NOTICED THAT THE SEAT ELEVATOR WAS LOOSELY MOUNTED. THE SERVICE TECHNICIAN NOTICED THAT THE LOWER BRACKET ON THE SEAT ELEVATOR COMPONENT HAD BROKE AND THAT THE UPPER MOUNTING SCREWS HAD ALSO BROKE OFF. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865608 PERMOBIL C500 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) C500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1