BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSORMEDICS

    MDR report key: 1361238 · Received January 30, 2009

    Report

    Report Number
    2021710-2009-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 30, 2009
    Manufacturer
    CARDINAL HEALTH 207, INC.
    Product Code
    LSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CARDINAL HEALTH ISSUED A RETURNED GOOD AUTHORIZATION (RGA) NUMBER TO THE DISTRIBUTOR, SOURCE MEDICAL TO RETURN THE DEVICE TO OUR MFG PLANT FOR EVAL AND REPAIR. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RECEIVED INTO THE MFG PLANT FOR EVAL. ONCE THE DEVICE HAS BEEN RECEIVED AND THE EVAL IS COMPLETE, A F/U MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS REPORTED TO CARDINAL HEALTH BY THE DISTRIBUTOR. "NOT ABLE TO PASS CIRCUIT CALIBRATION. CONFIRMED CIRCUIT TO BE OK-TESTED FINE ON OTHER UNIT. LIMIT (BLUE) BALLOON VALVE NOT INFLATING-MEASURING NO PRESSURE AT BULKHEAD LUER FITTING, OTHER PRESSURES OK. ADJUSTED PR2 3 ROTATIONS IN BOTH DIRECTIONS-SEEN NO CHANGE IN PRESSURE AT BULKHEAD. SUSPECT PR2. ALSO, UNIT DOESN'T ALARM WHEN TURNED OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSORMEDICS 73LSZ VENTILATOR, HIGH FREQUENCY LSZ CARDINAL HEALTH 207, INC. 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA