BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    86-003537 CUSTOM ANESTHESIA KIT

    MDR report key: 266164 · Received February 25, 2000

    Report

    Report Number
    1055236-2000-00005
    Event Type
    Malfunction
    Date Received
    February 25, 2000
    Date of Event
    January 27, 2000
    Manufacturer
    DEROYAL
    Product Code
    LRP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONTAINED INSIDE OF THE ANESTHESIA KIT IS A Y-ELBOW THAT CONNECTS THE TUBING AND THE MASK TOGETHER. AT THE VERY BEGINNING OF A SURGICAL PROCEDURE, THE Y-ELBOW LEAKED UNDER PRESSURE. NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 86-003537 CUSTOM ANESTHESIA KIT 7F1 ANESTHESIA KITS LRP DEROYAL * 63783

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other