BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIRK SPECIALTY SYSTEMS

    MDR report key: 344975 · Received July 27, 2001

    Report

    Report Number
    MW1022537
    Event Type
    Malfunction
    Date Received
    July 27, 2001
    Manufacturer
    KSS
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RESUSCITATION MASKS ON KIRK SPECIALTY SYSTEMS ADOLF CAPNO-FLO. RESUSCITATION BAGS ARE MALFORMED AND MAY NOT FIT ON BAG. MULTIPLE MALFORMATIONS FOUND IN VARYING LOTS OF BAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34056 KIRK SPECIALTY SYSTEMS RESUSCITATION BAG BTM KSS ADULT CAPNO-FLO BASIC 41023
    34057 KIRK SPECIALITY SYSTEMS RESUSCITATION BAG BTM KSS ADULT CAPNO-FLO BASIC 51034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA