BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVECARE +SFT SYSTEM WARNING:

    MDR report key: 8606032 · Received May 13, 2019

    Report

    Report Number
    0001526350-2019-00367
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    April 16, 2019
    Report Date
    July 16, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K151377
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). THE PREVIOUS REPAIR RECORD OF ACTIVE CARE + SFT UNIT SERIAL NUMBER (B)(4) IS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES. THE PREVIOUS REPAIR RECORD REVIEW FOUND NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. ON (B)(6) 2019, IT WAS REPORTED THAT PATIENT WAS FEELING PAIN LIKE ELECTRICITY IN THE LEGS AND THE CHARGING WIRE AND EXTRA SLEEVES WERE SENT FOR REPLACEMENT. THE SERVICE TECHNICIAN IS UNABLE TO EVALUATE THE DEVICE BECAUSE THE DEVICE IS NOT RETURNED TO FACILITY FOR REPAIR. THE SERVICE TECHNICIAN IS NOT ABLE TO REPRODUCE THE REPORTED ISSUE. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF REPORTED EVENT CANNOT BE DETERMINED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO MCS FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRO CODE- JOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING PAIN LIKE ELECTRICITY IN THE LEGS. NO ADDITIONAL CONSEQUENCES HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399594 ACTIVECARE +SFT SYSTEM WARNING: COMPRESSION THERAPY JOW ZIMMER SURGICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other