BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZM-930PA

    MDR report key: 4173660 · Received September 10, 2014

    Report

    Report Number
    2080783-2014-00051
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMERS ALLEGATION: BOTH THE TELE MONITOR IN MED/SURG AND OUR ICU BEDSIDE MONITOR DID NOT RECOGNIZE ASYSTOLE. REF MFR REPORT 8030229-2014-00051.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559818 ZM-930PA TELEMETRY TRANSMITTER MHX NIHON KOHDEN CORPORATION ZM-930PA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention