BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3915760 · Received June 12, 2014

    Report

    Report Number
    1828100-2014-00514
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED BY THE LAB EVAL. PER THE LAB EVAL, THE TECH OBSERVED THE TOUCHSCREEN NOT RESPONDING TO TOUCH COMMANDS. REPLACEMENT OF TOUCHSCREEN WITH LAB-USE ONLY TOUCHSCREEN ENABLED CENTRAL CONTROL MONITOR (CCM) TO FUNCTION PROPERLY, DETERMINING THE CUSTOMER'S TOUCHSCREEN WAS DEFECTIVE.

    Description of Event or Problem · 1

    THE PRODUCT SURVEILLANCE TECH REPORTED THAT DURING LAB EVAL FOR ANOTHER REPORTED ISSUE ON MDR #1828100-2014-00232, THE TOUCHSCREEN ON THE CENTRAL CONTROL MONITOR (CCM) WAS NOT FUNCTIONING PROPERLY. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346744 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (CCM) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802100

    Patients

    Seq Age Sex Outcome Treatment
    1