BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCURY MEDICAL

    MDR report key: 677896 · Received October 6, 2004

    Report

    Report Number
    1024404-2004-00007
    Event Type
    Malfunction
    Date Received
    October 6, 2004
    Report Date
    June 30, 2004
    Manufacturer
    MERCURY MEDICAL
    Product Code
    BYE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PEEP VALVE FAILED ON AN INFANT AMBOO BAG DURING USE- DIDN'T HOLD BACK PRESSURE. THERE WAS A PT INVOLVED, BUT THERE WAS NOT INJURY NOR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCURY MEDICAL PEEP VALVE BYE MERCURY MEDICAL NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO