BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTEM DELTA SYSTEM

    MDR report key: 7519474 · Received May 16, 2018

    Report

    Report Number
    3005792925-2018-00003
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    April 16, 2018
    Report Date
    May 16, 2018
    Manufacturer
    TEM INNOVATIONS GMBH
    Product Code
    JPA
    UDI-DI
    04260160470020
    PMA / PMN Number
    K101533
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS UNDER INVESTIGATION TO DETERMINE IF THERE WAS AN EVENT THAT ACTUALLY CAUSED A FIRE. THERE WAS NO INDICATION IN THE COMPLAINT THAT THERE WAS ANY DAMAGE TO THE LABORATORY. WE WILL FOLLOW UP WITH ADDITIONAL INFORMATION TO THE AGENCY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PIPETTE WOULD NOT CONNECT TO THEIR ROTEM DELTA ANALYZER, EVEN AFTER REBOOTING AND USING THE BACKUP PIPETTE. AN IL FIELD SERVICE ENGINEER WENT ON SITE AND OBSERVED SCORCHED CABLE, BOARD AND CONNECTION OUTLETS POSSIBLY FROM A FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362304 ROTEM DELTA SYSTEM WHOLE BLOOD HAEMOSTASIS SYSTEM JPA TEM INNOVATIONS GMBH 04260160470020

    Patients

    Seq Age Sex Outcome Treatment
    1