BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAERDAL INFLATE-A-SHIELD

    MDR report key: 374638 · Received January 30, 2002

    Report

    Report Number
    2425852-2001-00003
    Event Type
    Malfunction
    Date Received
    January 30, 2002
    Report Date
    November 13, 2001
    Manufacturer
    LAERDAL MEDICAL CORP.
    Product Code
    CBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS CUSTOMER RECEIVED A SAMPLE LIS (LAERDAL INFLATE-A-SHIELD) THAT WAS DEFECTIVE AND WOULD NOT INFLATE. THE CUSTOMER FOUND THE DEFECT UPON OPENING THE PACKAGE. THE SAMPLE WAS PROVIDED TO THE CUSTOMER TO BE EVALUATED FOR USE IN TRAINING CLASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAERDAL INFLATE-A-SHIELD CPR SHIELD - BARRIER DEVICE CBP LAERDAL MEDICAL CORP. NA 080301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA