BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBC PROBE

    MDR report key: 213055 · Received March 4, 1999

    Report

    Report Number
    MW1015830
    Event Type
    Malfunction
    Date Received
    March 4, 1999
    Date of Event
    August 26, 1998
    Report Date
    August 27, 1998
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORP.
    Product Code
    DTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MFR. ON 4/28/99: THE USER FACILITY DID NOT INCLUDE AN IBC PART NUMBER OR LOT NUMBER ON THE FORM. THE CO CALLED AND SPOKE WITH THE PERSON WHO INITIATED AND COMPLETED THE REPORT AND DUE TO THE TIME LAPSE, HE WAS UNABLE TO REMEMBER THE PART NUMBER OR LOT NUMBER. THE CO DOES NOT HAVE THE PRODUCT IN QUESTION TO PERFORM EVALUATIONS, TESTS, OR FAILURE ANALYSIS. DURING THE CO'S PHONE CONVERSATION, THE CO INQUIRED ABOUT THE AVAILABILITY OF THE PRODUCT AND WAS INFORMED THAT IT HAD BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBC PROBE INLINE ARTERIAL SENSOR DTY INTERNATIONAL BIOPHYSICS CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *