BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE ADULT MANUAL RESUSCITATOR

    MDR report key: 488965 · Received October 9, 2003

    Report

    Report Number
    1217052-2003-00055
    Event Type
    Malfunction
    Date Received
    October 9, 2003
    Date of Event
    August 29, 2003
    Report Date
    September 9, 2003
    Manufacturer
    PORTEX, INC., GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PREPPING A ROOM WITH A RESUSCITATOR, THE MASK WAS MISSING OUT OF THE PACKAGE. ANOTHER RESUSCITATOR WAS OBTAINED. NO PT INVOLVEMENT AS RESUSCITATOR WAS NOT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE ADULT MANUAL RESUSCITATOR MANUAL RESUSCITATOR SYSTEM BTM PORTEX, INC., GALEMED CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA