BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNT SENSOR SYS500

    MDR report key: 2904133 · Received January 3, 2013

    Report

    Report Number
    1124841-2013-00015
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 12, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION: THEREFORE, THE INVESTIGATION HAS NOT BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT, DURING PRIME, THE SHUNT SENSOR LEAKED. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PT INVOLVEMENT AS THIS OCCURRED DURING PRIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362 SUNT SENSOR SYS500 BLOOD-GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP CDI510H PG11D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK