BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL C500

    MDR report key: 5187830 · Received October 29, 2015

    Report

    Report Number
    1221084-2015-00038
    Event Type
    Death
    Date Received
    October 29, 2015
    Date of Event
    September 23, 2015
    Report Date
    October 27, 2015
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    PMA / PMN Number
    K991658
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DHR WAS REVIEWED AND UNIT WAS BUILT ACCORDING TO SPECIFICATION. FURTHER INVESTIGATION IS REQUIRED TO VERIFY THE EVENTS LEADING TO THE REPORTED INCIDENT. AT TIME OF THIS REPORT, ALL INFORMATION RECEIVED HAS BEEN SECOND HAND ACCOUNTS, ALL OF WHICH DIFFER SLIGHTLY AS TO THE CAUSE OF THE REPORTED EVENT. ATTEMPTS HAVE BEEN MADE TO CONTACT THE INITIAL REPORTER OF THE EVENT (SPOUSE) WITH NO RESULTS. INVESTIGATION WILL CONTINUE TO DETERMINE THE CONTRIBUTING FACTOR OF THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE FILED WHEN FURTHER INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT CLIENT FELL OUT OF HIS CHAIR HAVING TO BE TAKEN THE HOSPITAL WHERE HE LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718214 PERMOBIL C500 POWER WHEELCHAIR ITI PERMOBIL INC. C500

    Patients

    Seq Age Sex Outcome Treatment
    1 Death