BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH SILKO REBREATHING BAG, 2.3L

    MDR report key: 2833502 · Received October 30, 2012

    Report

    Report Number
    9610520-2012-00015
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 18, 2012
    Manufacturer
    WILLY RUSCH GMBH
    Product Code
    BYW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING USE ON A PT, WHEN THE BALLOON WAS BEING INFLATED, IT DEFLATED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH SILKO REBREATHING BAG, 2.3L ANESTHESIA BREATHING BAG BYW WILLY RUSCH GMBH P1117405

    Patients

    Seq Age Sex Outcome Treatment
    1