BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEB-9400A

    MDR report key: 8220327 · Received January 4, 2019

    Report

    Report Number
    8030229-2019-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 7, 2018
    Report Date
    November 6, 2019
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    IKN
    UDI-DI
    04931921102183
    PMA / PMN Number
    K010590
    Removal / Correction Number
    NOT APPLICABLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT DETAILS: THE CUSTOMER REPORTED ON (B)(6) 2018 THAT THEY WERE GETTING BURNING SMELL FROM POWER SUPPLY. THE SYSTEM HAD SHUT DOWN. THE CUSTOMER GOT IT RUNNING FOR A LITTLE WHILE IN SAFE MODE BUT WANTED IT TO BE CHECKED OUT. SERVICE REQUESTED: THE CUSTOMER REQUESTED THE DEVICE TO BE EVALUATED SERVICE PROVIDED: THE CUSTOMER DID NOT SEND IN THE UNIT FOR REPAIR/EVALUATION INVESTIGATION RESULT: THE UNIT WAS PLACED INTO SERVICE ON (B)(6) 2017, WHICH IS OVER 1 YEAR AT THE TIME OF THE REPORTED ISSUE. A REVIEW OF DEVICE HISTORY FOUND NO PREVIOUSLY REPORTED SIMILAR ISSUE WITH THIS DEVICE. SIMILAR TICKETS USING "MEB 9400A BURNING SMELL POWER SUPPLY" AND GAVE NO RESULT. REVIEW OF TICKETS REPORTED BY THE NEUROLOGICAL MEDICINE FOUND NO SIMILAR REPORTED ISSUE. BASED ON THE DEVICE SERVICE HISTORY, COMPLAINTS FROM CUSTOMER SITE AND SIMILAR SEARCH QUERY, NO ADVERSE TREND IS SUSPECTED WITH THE DEVICE. THE ROOT CAUSE OF THE ISSUE WAS UNABLE TO BE DETERMINED DUE TO LIMITED INFORMATION IN THE COMPLAINT RECORD AND THE DEVICE WAS NOT RETURNED TO NK FOR REPAIR/EVALUATION. THE CUSTOMER WAS INFORMED ABOUT THE HAZARD THAT CAN OCCUR TO THE PATIENTS. THE DEVICE WAS BEING USED BY THE CUSTOMER. NO FURTHER COMPLAINT WAS REPORTED WITH THE DEVICE. CORRECTED INFORMATION: F9. APPROXIMATE AGE OF DEVICE: INCORRECTLY CALCUATED G4. DATE RECEIVED BY MANUFACTURER: SHOULD BE (B)(6) 2018 NOT (B)(6) 2019 AS LISTED ON MDR INITIAL REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE WAS A BURNING SMELL FROM THE POWER SUPPLY FROM THEIR MEB-9400A SYSTEM AFTER IT HAD SHUTDOWN. THEY GOT IT RUNNING FOR A LITTLE WHILE IN SAFE MODE AND WOULD LIKE THE SYSTEM EVALUATED. HOWEVER, THEY HAVE ORDERED A REPLACEMENT AND ARE AWAITING ITS ARRIVAL BEFORE TAKING THIS UNIT OFFLINE. THE CALLER AND THEIR IT PERSON EXPRESSED THEY WANTED TO KEEP THE SYSTEM IN USE AFTER I EXPLAINED THE SYSTEM MAY BE A HAZARD TO THE PATIENTS. NO PATIENT HARM OR INJURY REPORTED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THERE WAS A BURNING SMELL FROM THE POWER SUPPLY FROM THEIR MEB-9400A SYSTEM AFTER IT HAD SHUTDOWN. THEY GOT IT RUNNING FOR A LITTLE WHILE IN SAFE MODE AND WOULD LIKE THE SYSTEM EVALUATED. HOWEVER, THEY HAVE ORDERED A REPLACEMENT AND ARE AWAITING ITS ARRIVAL BEFORE TAKING THIS UNIT OFFLINE. THE CALLER AND THEIR IT PERSON EXPRESSED THEY WANTED TO KEEP THE SYSTEM IN USE AFTER I EXPLAINED THE SYSTEM MAY BE A HAZARD TO THE PATIENTS. NO PATIENT HARM OR INJURY REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A BURNING SMELL FROM THE POWER SUPPLY FROM THEIR MEB-9400A SYSTEM AFTER IT HAD SHUTDOWN. THEY GOT IT RUNNING FOR A LITTLE WHILE IN SAFE MODE AND WOULD LIKE THE SYSTEM EVALUATED. HOWEVER, THEY HAVE ORDERED A REPLACEMENT AND ARE AWAITING ITS ARRIVAL BEFORE TAKING THIS UNIT OFFLINE. THE CALLER AND THEIR IT PERSON EXPRESSED THEY WANTED TO KEEP THE SYSTEM IN USE AFTER I EXPLAINED THE SYSTEM MAY BE A HAZARD TO THE PATIENTS. NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9632 MEB-9400A ELECTROMYOGRAPH IKN NIHON KOHDEN CORPORATION MEB-9400A NOT APPLICABLE 04931921102183

    Patients

    Seq Age Sex Outcome Treatment
    1