BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDI-BLUE

    MDR report key: 38952 · Received September 19, 1996

    Report

    Report Number
    MW1009954
    Event Type
    Malfunction
    Date Received
    September 19, 1996
    Date of Event
    September 3, 1996
    Report Date
    September 5, 1996
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY CARE PRACTITIONER COMPLAINED THAT THE MANUAL RESUSCITATOR TEE ADAPTER HAD HAIRLINE CRACKS THEREBY CAUSING A LOOSE CONNECTION AND/OR A LEAK. DURING INVESTIGATION IT WAS NOTED THAT THIS PROBLEM INVOLVED MANY LOT CODE NUMBERS. PRODUCT WAS PULLED FROM STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDI-BLUE PEDIATRIC RESUSCITATOR BTM VITAL SIGNS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other