BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATASCOPE

    MDR report key: 4080818 · Received September 4, 2014

    Report

    Report Number
    MW5038125
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MINDRAY
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TELEMETRY MONITOR MALFUNCTION AND MONITOR TECH UNABLE TO VIEW PATIENT RHYTHM FOR LTAC PATIENTS AT 15:45. MALFUNCTION INVOLVED A TOTAL OF 6 PATIENTS WHERE PATIENT TELEMETRY WAS NOT VIEWABLE BY TECH. MINDRAY REPRESENTATIVE TROUBLESHOOTING AND UNABLE TO IDENTIFY PROBLEM. ON (B)(6) 2014, CEO REQUESTING ON-SITE VISIT FOR TELEMETRY EVALUATION AND REPAIR. MINDRAY ON SITE NAD TELEMETRY REPAIRED AT 1830. PATIENTS REMAIN SAFE AND FREE FROM HARM DURING THE TIME PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539517 DATASCOPE TELEMETRY SERVER MHX MINDRAY 099800870001

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR