BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEE-2000A

    MDR report key: 9759588 · Received February 26, 2020

    Report

    Report Number
    8030229-2020-00116
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 5, 2020
    Report Date
    June 15, 2020
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    GWF
    UDI-DI
    04931921118054
    PMA / PMN Number
    K142624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILS OF THE COMPLAINT: ON (B)(6) 2020, CUSTOMER AT GREAT AMERICA LEASING CORP REPORTED THE FOLLOWING: "UNIT 00164 HAS A FAULTY AMPLIFIER CORD. IT WILL DISCONNECT IF IT'S NOT IN A CERTAIN POSITION". THE ISSUE WAS REPORTED TO OCCUR FOR MEE-2000A SN: (B)(6)(A/DELL-5580-LT SN: DWQHST2). INVESTIGATION SUMMARY: THE ROOT CAUSE OF THE CONNECTION FAILURE IS NOT KNOWN AS EVALUATION OF THE COMPLAINT PART (JB-232A SN (B)(6)) WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE AMPLIFIER CORD WAS TESTED AND FOUND TO BE WORKING NORMALLY WITHOUT ISSUE. ADDITIONAL DEVICE INFORMATION: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE MEE-2000A: D11 & C2: CONCOMITANT MEDICAL DEVICE: JB-232B: SERIAL NUMBER (B)(6). ADDITIONAL INFORMATION: B4. DATE OF THIS REPORT. F6. DATE USER FACILITY/IMPORTER BECAME AWARE OF THE EVENT. F7. TYPE OF REPORT. F11. DATE REPORT SENT TO FDA. F13. DATE REPORT SENT TO MANUFACTURER. G4. DATE RECEIVED BY MANUFACTURER. G7. TYPE OF REPORT. H2. IF FOLLOW-UP, WHAT TYPE? H3 DEVICE EVALUATED BY MANUFACTURER? H6. EVENT PROBLEM AND EVALUATION CODES. H10. ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MEE-2000A AMPLIFIER CORD FAILED DURING A PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE MEE-2000A AMPLIFIER CORD FAILED DURING A PROCEDURE. NO PATIENT HARM WAS REPORTED. THE DEVICE HAS BEEN RETURNED TO NIHON KOHDEN AND IS AWAITING EVALUATION. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL DEVICE INFORMATION: THE FOLLOWING DEVICES WERE USED IN CONJUNCTION WITH THE MEE-2000A: CONCOMITANT MEDICAL DEVICE: JB-232B: SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MEE-2000A AMPLIFIER CORD FAILED DURING A PROCEDURE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216473 MEE-2000A EVOKED RESPONSE ELECTRIC STIMULATOR GWF NIHON KOHDEN CORPORATION MEE-2000A NA 04931921118054

    Patients

    Seq Age Sex Outcome Treatment
    1 JB-232B.| JB-232B.