BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEP-4208A

    MDR report key: 4143660 · Received August 12, 2014

    Report

    Report Number
    8030229-2014-00039
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K040395
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS RETURNED AND EVALUATED. THE ISSUE COULD NOT BE DUPLICATED. THE UNIT WAS TESTED FOR SEVERAL DAYS BY MONITORING A TRANSMITTER ATTACHED TO A SIMULATOR, HOWEVER, THERE WAS NO SIGN OF COMMUNICATION LOSS. THE UNIT WAS SHIPPED BACK TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    DEVICE LOANER SENT TO CUSTOMER AND RETURN OF DEFECTIVE DEVICE REQUESTED FOR FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479997 WEP-4208A CENTRAL TELEMETRY SYSTEM MHX NIHON KOHDEN CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1