BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON RCI

    MDR report key: 8288302 · Received January 30, 2019

    Report

    Report Number
    8288302
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 2, 2019
    Report Date
    January 11, 2019
    Manufacturer
    TELEFLEX INCORPORATED
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE AMBU BAGS ON THE RRT STRETCHER AT THE 6TH FLOOR ELEVATOR AND THE 6TH FLOOR CODE CART HAD DEFLATED MASKS. IN THE EVENT THAT AN AMBU IS NEEDED TO DELIVER RESCUE BREATHS, ONE WOULD NOT BE ABLE TO GET A GOOD ENOUGH SEAL TO SUCCESSFULLY DELIVER BREATHS. MATERIALS MANAGEMENT FOUND DEFLATED MASKS IN OTHER AREAS OF THE HOSPITAL AS WELL AS MASKS THAT HAD NO EXPIRATION DATES. WE HAVE REACHED OUT TO OTHER FACILITIES AND THEY DO NOT HAVE THE SAME PROBLEM. THE DEFLATED MASKS AND MASKS WITHOUT EXPIRATION DATES HAVE BEEN SENT TO THE VENDOR. THERE IS NO UNDERLYING LOT#, BUT MULTIPLE LOT#'S ARE INVOLVED. KNOWN LOT#S: LOT# 180314 EXP DATE: 3-14-2021, LOT# 170717 EXP DATE: 7-17-2020, LOT # 171010 EXP DATE: N/A. MANUFACTURER RESPONSE FOR AMBU MASK, (BRAND NOT PROVIDED) (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81561 HUDSON RCI VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM TELEFLEX INCORPORATED IPN044946

    Patients

    Seq Age Sex Outcome Treatment
    1