BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAS MODULE 3 MONITOR

    MDR report key: 3091280 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00543
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    February 6, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    BZK
    PMA / PMN Number
    062754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SERVICE REPS REPLACED THE UNITS GAS BENCH. VERIFIED PROPER OPERATION, AND MADE ALL CHECKS WITHIN FACTORY SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AND THE GAS MODULE WOULD NOT ZERO OR READ GASES, WHICH MAY HAVE RESULTED IN A LOSS OF GAS MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186749 GAS MODULE 3 MONITOR GAS MONITOR BZK MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1