BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYBQ 2 CHANNEL V2.01

    MDR report key: 3022993 · Received March 21, 2013

    Report

    Report Number
    9615050-2013-00458
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING TESTING IT WAS FOUND AT POWER UP, THE DEVICE DISPLAYED A WHITESCREEN ERROR AND THE DEVICE SOUNDED AN AUDIBLE ALARM FROM THE SECONDARY BEEPER. THIS WAS DUE TO A DEPLETED BACK UP BATTERY THAT CAUSED CORRUPTION OF THE RANDOM ACCESS MEMORY (RAM) DATA RESULTING IN A WHITESCREEN ERROR. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A WHITESCREEN ERROR. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118360 SYBQ 2 CHANNEL V2.01 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA